Search Clinical Trials
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A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamo1
Merck Sharp & Dohme LLC
Squamous Non-small Cell Lung Cancer
Researchers want to know if intismeran autogene (the study treatment) given with
pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small
cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune
system attack their specific cancer.
The goal1 expand
Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment. Type: Interventional Start Date: Dec 2025 |
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Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
Washington University School of Medicine
Multiple Myeloma
The outcomes in patients with relapsed multiple myeloma refractory to triple-therapy
(anti-CD38, immunomodulatory drugs (IMiD) and proteasome inhibitors (PI)) remain poor.
These patients are eligible for chimeric antigen receptor T-cells (CAR-T), which rely on
redirecting autologous T-cells to clea1 expand
The outcomes in patients with relapsed multiple myeloma refractory to triple-therapy (anti-CD38, immunomodulatory drugs (IMiD) and proteasome inhibitors (PI)) remain poor. These patients are eligible for chimeric antigen receptor T-cells (CAR-T), which rely on redirecting autologous T-cells to clear myeloma cells by targeting B-cell maturation antigen (BCMA). BCMA CAR-T therapy is not curative, and unlike autologous stem cell transplant, there is currently no standard for maintenance therapy post CAR-T which could potentially increase MRD rates and extend progression-free survival. Selinexor is an exportin (XPO1) inhibitor with direct anti-tumor effect used often as an adjunct with other agents as bridging therapy prior to CAR-T. As selinexor does not affect T-cell yields or fitness, T-cell collection on selinexor for CAR-T manufacturing is safe. The aim of this study is to evaluate the safety and toxicity of selinexor in triple-exposed or refractory multiple myeloma patients with high-risk features (adverse risk cytogenetics, less than complete response (CR) post CAR-T, or extramedullary disease) following BCMA CAR-T therapy. The investigators hypothesize that selinexor as maintenance therapy following CAR-T has the potential to act synergistically with CAR-T cells leading to more durable responses. Type: Interventional Start Date: Mar 2026 |
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Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy1
Washington University School of Medicine
Multiple Myeloma
Multiple Myeloma in Relapse
Multiple Myeloma, Refractory
CAR-T cell therapy is an emerging treatment modality in relapsed and refractory multiple
myeloma (MM). CAR-T therapy in MM relies on directing autologous T-cells to detect and
clear myeloma cells expressing B-cell Maturation Antigen (BCMA). While BCMA CAR-T
cell-treated patients achieve an excellen1 expand
CAR-T cell therapy is an emerging treatment modality in relapsed and refractory multiple myeloma (MM). CAR-T therapy in MM relies on directing autologous T-cells to detect and clear myeloma cells expressing B-cell Maturation Antigen (BCMA). While BCMA CAR-T cell-treated patients achieve an excellent overall response rate, their response is often not durable. NT-I7 promotes CAR-T cell expansion and efficacy in pre-clinical lymphoma models. In patients receiving CD19-directed CAR-T therapy for lymphoma, NT-I7 augmented CAR-T expansion while being safe and tolerable. The impact of NT-I7 on BCMA CAR-T cells in multiple myeloma is unknown. This is a two-stage, multicenter, phase IB study, with a dose escalation stage leading into a two-arm, double blind, placebo-controlled, randomized dose expansion stage testing the safety and toxicity of adding NT-I7 to BCMA CAR-T therapy in patients with relapsed and refractory multiple myeloma. The hypothesis is that NT-I7 will promote CAR-T expansion and persistence which will enhance clearance of MM, while maintaining a favorable safety and toxicity profile. Patients receiving standard of care BCMA CAR-T (cilta-cel) will be randomized to either NT-I7 or placebo. Correlative studies will evaluate CAR-T cell expansion, persistence, immune-phenotype, function and correlate with clinical outcomes. Type: Interventional Start Date: Jun 2026 |
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Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
University of California, San Francisco
BRAF V600 Mutation
Low-grade Glioma
Low Grade Glioma of Brain
Recurrent Low Grade Glioma
This phase II trial studies how well de-escalating the drugs dabrafenib and trametinib
works in treating patients with low-grade gliomas that have a BRAF V600 gene mutation.
Dabrafenib and trametinib are in a class of medications called kinase inhibitors. They
work by blocking the action of abnorma1 expand
This phase II trial studies how well de-escalating the drugs dabrafenib and trametinib works in treating patients with low-grade gliomas that have a BRAF V600 gene mutation. Dabrafenib and trametinib are in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals tumor cells to multiply. This helps stop the spread of tumor cells. This trial may help doctors determine the best dosing strategy for patients who have received dabrafenib and trametinib for 12-24 months: Either stopping dabrafenib and trametinib completely or slowly reducing the dose for an additional 6 months. Type: Interventional Start Date: Nov 2025 |
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A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in1
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Lymphoma
The purpose of this study is to evaluate the safety and efficacy of lisocabtagene
maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in
transplant-ineligible Primary Central Nervous System Lymphoma (PCNSL). expand
The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in transplant-ineligible Primary Central Nervous System Lymphoma (PCNSL). Type: Interventional Start Date: Nov 2025 |
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Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease
Washington University School of Medicine
Crohn Disease (CD)
The purpose of this research study is to evaluate what type of treatment will be
beneficial for people with Crohn's disease and difficult to treat inflammation in the
small bowel. Current therapies are used to control the inflammation due to Crohn's
disease in your digestive tract. In some patients1 expand
The purpose of this research study is to evaluate what type of treatment will be beneficial for people with Crohn's disease and difficult to treat inflammation in the small bowel. Current therapies are used to control the inflammation due to Crohn's disease in your digestive tract. In some patients, those therapies are not sufficient to fully treat the disease. This objective of this study is to evaluate the efficacy of a different type of therapy, tirzepatide, that may promote healing of the affected intestinal segment. To evaluate the efficacy of this medication, a member of the research team will ask patients questions about how they feel and observe whether this medication heals the their bowel at colonoscopy. A member of the research team will also use blood samples, stool samples and samples of the small intestine taken during a colonoscopy to understand how tirzepatide helps heal the intestine. Type: Interventional Start Date: May 2025 |
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Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis
Rapamycin Holdings Inc.
Familial Adenomatous Polyposis (FAP)
The main goal of this clinical trial is to learn if the drug eRapa works to slow down the
progression of disease in patients diagnosed with Familial Adenomatous Polyposis (FAP).
Researchers will compare eRapa to Placebo. The questions to be answered by this trial
are:
- Does taking eRapa help t1 expand
The main goal of this clinical trial is to learn if the drug eRapa works to slow down the progression of disease in patients diagnosed with Familial Adenomatous Polyposis (FAP). Researchers will compare eRapa to Placebo. The questions to be answered by this trial are: - Does taking eRapa help to slow down the progression of the disease in patients with FAP? - Is eRapa a safe treatment for patients diagnosed with FAP? - What is the effect of eRapa on the number of polyps found in GI tract of patients diagnosed with FAP? - How does treatment with eRapa affect a patient's quality of life? Participants will: - Take eRapa or placebo once per day every other week until disease progresses (gets worse), stops taking part in the trial or dies. - Visit the clinic once every 3 months for check ups and tests. - Have an endoscopy at the start of the trial and then every 6 months to check on whether the disease is getting better or worse. Type: Interventional Start Date: Jul 2025 |
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Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalu1
Alliance for Clinical Trials in Oncology
Castration-Sensitive Prostate Carcinoma
Metastatic Prostate Adenocarcinoma
Stage IVB Prostate Cancer AJCC v8
This phase III trial compares the effect of adding docetaxel to hormonal therapy and
apalutamide versus hormonal therapy and apalutamide alone in treating patients with
prostate cancer that has spread from where it first started (primary site) to other
places in the body (metastatic). Docetaxel is1 expand
This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone. Type: Interventional Start Date: Dec 2025 |
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A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated With Percutane1
Society of Interventional Oncology
Bone Cancer Metastatic
The objective of this study is to evaluate real-world outcomes (e.g., pain, patient
reported outcomes, skeletal related events, healthcare utilization, etc.) in patients
treated with both percutaneous ablation and palliative radiation therapy (RT). expand
The objective of this study is to evaluate real-world outcomes (e.g., pain, patient reported outcomes, skeletal related events, healthcare utilization, etc.) in patients treated with both percutaneous ablation and palliative radiation therapy (RT). Type: Observational Start Date: Oct 2025 |
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Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular The1
Washington University School of Medicine
Hematologic Malignancy
Solid Tumor
Sickle Cell Disease
Aplastic Anemia
Immune Deficiency
The investigators will conduct a pilot feasibility and efficacy trial of a newly
developed family health communication tool (called Let's Get REAL) in increasing youth
involvement in real-time stem cell transplant and cellular therapy decisions (SCTCT). The
investigators will pilot the intervention1 expand
The investigators will conduct a pilot feasibility and efficacy trial of a newly developed family health communication tool (called Let's Get REAL) in increasing youth involvement in real-time stem cell transplant and cellular therapy decisions (SCTCT). The investigators will pilot the intervention among 24 youth and their parents, stratified by youth age (stratum 1, 8-12 years of age and stratum 2, 13-17 years of age). Type: Interventional Start Date: Nov 2024 |
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Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
Alliance for Clinical Trials in Oncology
Castration-Resistant Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8
This phase II trial evaluates whether genetic testing in prostate cancer is helpful in
deciding which study treatment patients are assigned. Patient cancer tissue samples are
obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid
(DNA) and ribonucleic acid (RNA) a1 expand
This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing Type: Interventional Start Date: Feb 2025 |
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Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive1
Canadian Cancer Trials Group
Prostate Cancer (Adenocarcinoma)
This study is being done to answer the following question: can the chance of prostate
cancer growing or spreading be lowered by adding a drug to the usual combination of
drugs?
This study would like to find out if this approach is better or worse than the usual
approach for prostate cancer.
The u1 expand
This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs? This study would like to find out if this approach is better or worse than the usual approach for prostate cancer. The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI). Type: Interventional Start Date: May 2025 |
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Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl
Washington University School of Medicine
Alzheimer Disease
The purpose of this research study is to determine the safety of a radiotracer
18F-Fluselenamyl using positron emission tomography (PET) imaging. expand
The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging. Type: Observational Start Date: Nov 2023 |
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A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizuma1
Merck Sharp & Dohme LLC
Breast Neoplasms
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in
combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in
participants with hormone receptor positive/human epidermal growth factor receptor-2
negative (HR+/HER2-) unresectable locally ad1 expand
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants. Type: Interventional Start Date: Apr 2024 |
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Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mut1
Novartis Pharmaceuticals
Lymphatic Malformations
The main purpose of this study in participants with PIK3CA-mutated LyM is to assess the
change in radiological response and symptom severity upon treatment with alpelisib
film-coated tablets (FCT) as compared to placebo. expand
The main purpose of this study in participants with PIK3CA-mutated LyM is to assess the change in radiological response and symptom severity upon treatment with alpelisib film-coated tablets (FCT) as compared to placebo. Type: Interventional Start Date: Nov 2023 |
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Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
Stanford University
Lymphoid Leukemia
To use a consistent and standardized platform to retrospectively and prospectively study
children and young adults with B cell malignancies receiving Immunotherapy, blinatumomab
and/or inotuzumab ozogamicin. expand
To use a consistent and standardized platform to retrospectively and prospectively study children and young adults with B cell malignancies receiving Immunotherapy, blinatumomab and/or inotuzumab ozogamicin. Type: Observational Start Date: Jun 2023 |
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Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
Novartis Pharmaceuticals
Prostate Cancer
The purpose of this post-marketing study is to further characterize the long-term outcome
of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as
[177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study
also seeks to further characterize (as1 expand
The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other AAA617 causally related serious adverse event(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials. Type: Interventional Start Date: Aug 2023 |
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Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotranspo1
Washington University School of Medicine
Pediatric Brain Tumor
Pediatric Solid Tumor
This is a pilot phase Ib study of the safety of dapagliflozin (in addition to standard of
care treatment) for the treatment of pediatric patients with recurrent brain tumors and
relapsed/refractory solid tumors. The primary hypothesis is that dapagliflozin is
well-tolerated and safe to use in this1 expand
This is a pilot phase Ib study of the safety of dapagliflozin (in addition to standard of care treatment) for the treatment of pediatric patients with recurrent brain tumors and relapsed/refractory solid tumors. The primary hypothesis is that dapagliflozin is well-tolerated and safe to use in this patient population. The investigators also hypothesize that dapagliflozin will be efficacious as an adjunct to front-line chemotherapy assessed by decreased tumor markers mediated by its pleiotropic metabolic effects. Type: Interventional Start Date: Apr 2023 |
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Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in Peo1
AIDS Malignancy Consortium
HIV Infection
Tobacco-Related Carcinoma
This clinical trial evaluates the usefulness of using a smartphone-based HIV-specific
smoking cessation intervention at the time of lung cancer screening in helping people
living with HIV quit smoking. Positively Smoke Free - Mobile may help patients with HIV
quit smoking. expand
This clinical trial evaluates the usefulness of using a smartphone-based HIV-specific smoking cessation intervention at the time of lung cancer screening in helping people living with HIV quit smoking. Positively Smoke Free - Mobile may help patients with HIV quit smoking. Type: Interventional Start Date: Mar 2023 |
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A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerat1
Eli Lilly and Company
Ulcerative Colitis
Ulcerative Colitis Chronic
Inflammatory Bowel Diseases
Crohn's Disease
The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in
pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study
will last about 172 weeks and may include up to 44 visits. Additional treatment may be
available to participants via a Contin1 expand
The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period. Type: Interventional Start Date: May 2021 |
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Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to R1
David Oh
Prostate Adenocarcinoma
Prostate Cancer
Localized Prostate Cancer
This phase II trial studies how well atezolizumab works alone or in combination with
etrumadenant or tocilizumab in treating men with localized prostate cancer before radical
prostatectomy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help
the body's immune system attack the1 expand
This phase II trial studies how well atezolizumab works alone or in combination with etrumadenant or tocilizumab in treating men with localized prostate cancer before radical prostatectomy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Androgens can cause the growth of prostate cancer cells. IL-6 is expressed by prostate cancer and within the tumor microenvironment and shown to enhance prostate cancer and disease progression. Treatment with an anti-IL-6 antibody such as tocilizumab may inhibit cancer progression. Giving atezolizumab in combination with etrumadenant or tocilizumab may work better in treating prostate cancer. Type: Interventional Start Date: Oct 2019 |
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Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia
SPIRE Therapeutics Inc.
Fibromyalgia
The goal of this clinical trial is to evaluate a new noninvasive brain stimulation
intervention for fibromyalgia and to determine its effectiveness in reducing pain.
Participants will receive four treatments over the course of one month and will complete
surveys at multiple time points throughout t1 expand
The goal of this clinical trial is to evaluate a new noninvasive brain stimulation intervention for fibromyalgia and to determine its effectiveness in reducing pain. Participants will receive four treatments over the course of one month and will complete surveys at multiple time points throughout the 16-week study. Type: Interventional Start Date: Dec 2025 |
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Study of COYA 302 for the Treatment of ALS
Coya Therapeutics
Amyotrophic Lateral Sclerosis (ALS)
The ALSTARS trial will be conducted across 20-25 sites in the US and Canada, and will
evaluate the safety and efficacy of an investigational treatment called COYA 302 for
adults with Amyotrophic Lateral Sclerosis (ALS).
COYA 302 is an investigational and proprietary biologic combination therapy wi1 expand
The ALSTARS trial will be conducted across 20-25 sites in the US and Canada, and will evaluate the safety and efficacy of an investigational treatment called COYA 302 for adults with Amyotrophic Lateral Sclerosis (ALS). COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. It is comprised of low dose interleukin-2 (LD IL-2) and DRL_AB (a biosimilar candidate for abatacept). Participants will be randomly assigned to receive one of 2 regimens of COYA 302 or placebo (an inactive substance) in a 1:1:1 ratio for 24 weeks in the double-blind (DB) period. Those who complete this part of the study will be eligible to receive one of the two regimens of COYA 302 for an additional 24 weeks in a blinded active extension phase (EXT). The study will assess changes in disease progression using established ALS clinical outcome measures, including the ALS Functional Rating Scale-Revised (ALSFRS-R), neurofilament (NfL), maximal inspiratory pressure (MIP), slow vital capacity (SVC), and neurological assessments. Additional objectives include evaluation of biomarkers and safety through routine clinical assessments and adverse event monitoring. Type: Interventional Start Date: Oct 2025 |
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Diagnosing Epilepsy To EffeCT Change
Epiminder America, Inc.
Epilepsy
Epilepsy (Treatment Refractory)
The purpose of this research is to address the challenges of diagnosing and long-term
management of epilepsy in participants whose seizures are not well captured by standard
electroencephalography (EEG) tests and who cannot use or are not able to use more
standard monitoring techniques. This resear1 expand
The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational. Participants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends. All participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit. Type: Interventional Start Date: Dec 2025 |
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NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtag1
Washington University School of Medicine
Large B-cell Lymphoma
Diffuse large B-cell lymphoma is the most commonly occurring subtype of non-Hodgkin
lymphoma, but treatment is often not curative, with as many as 50% of patients with
adverse risk factors developing relapsed/refractory disease. CAR T-cell therapy has
revolutionized modern cancer therapy, with axic1 expand
Diffuse large B-cell lymphoma is the most commonly occurring subtype of non-Hodgkin lymphoma, but treatment is often not curative, with as many as 50% of patients with adverse risk factors developing relapsed/refractory disease. CAR T-cell therapy has revolutionized modern cancer therapy, with axicabtagene ciloleucel and lisocabtagene maraleucel (anti-CD19 CAR T-cell therapies) FDA approved for second- or later-line treatment of relapsed/refractory large B-cell lymphoma. IL-7 plays a crucial role in T-cell homeostasis by inducing thymic differentiation, peripheral expansion, and extrathymic differentiation. It is the main regulator of T-cell hemostasis, inducing T-cell growth and proliferation in lymphopenic patients. There is data that suggests that exposure of T-cells to IL-7 may expand T-cells, prevent T-cell exhaustion, and improve effector functions. NT-I7 is a long-acting human IL-7 cytokine which has been shown in nonclinical studies to increase peripheral T-cells, antitumor efficacy, and tumor infiltrating lymphocytes, either as a monotherapy or in combination with chemo/radiotherapy and/or immune checkpoint inhibitors and CAR T therapy. This study is testing the hypothesis that the administration of NT-I7 following standard of care (SOC) approved CD19 CAR T-cell therapies for subjects with relapsed/refractory large B-cell lymphoma (LBCL) will be safe and tolerable and may increase the expansion and persistence of CAR T-cells in vivo, which may result in increased tumor response rate and improved clinical outcomes. Type: Interventional Start Date: Mar 2026 |