A Study of TLN-254 in Participants With Relapsed or Refractory T-cell Lymphoma

Purpose

The primary purpose of this study is to evaluate the anti-tumor activity of TLN-254 monotherapy in participants with relapsed or refractory T-cell lymphoma.

Condition

  • Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Age: 1. At least 18 years of age at the time of signing the informed consent form (ICF). Type of Participant and Disease Characteristics: 2. Cohort 1: Peripheral T-cell lymphoma (PTCL) that has relapsed after, or not responded to at least one prior systemic treatment regimen. Participants with Anaplastic large cell lymphoma (ALCL) should have received prior brentuximab vedotin treatment. - Nodal T-follicular helper (TFH) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma). - Nodal TFH cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type. - Nodal TFH cell lymphoma, not otherwise specified (NOS); Follicular helper T-cell lymphoma, NOS. - PTCL, NOS. - Anaplastic large-cell lymphoma, Alkaline phosphatase (ALK) positive. - Anaplastic large-cell lymphoma, ALK negative. Cohort 2: Relapsed/refractory CTCL which has relapsed after, or not responded to at least two prior systemic treatments. - Sezary syndrome - Mycosis fungoides 3. Participant must have measurable disease at study entry. 4. Freshly biopsied or archival tissue available. Diagnostic Assessments: 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 6. Adequate organ function. Contraception: 7. Participants must accept and follow the pregnancy prevention plan.

Exclusion Criteria

Medical Conditions: 1. Participants must not have prior systemic anti-cancer treatment less than or equal to (≤) 5 half-lives or 4 weeks, allogeneic SCT≤90 days or autologous SCT ≤60 days prior to study intervention initiation. 2. Participants must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study. 3. Current or past history of central nervous system (CNS) involvement. Other Exclusions: - Pregnant or lactating women. - Unable to swallow tablets.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: TLN-254 Single Agent
  • Drug: TLN-254
    TLN-254 will be administered orally at a specified dose on specified days depending on treatment allocation.
Experimental
Cohort 2: TLN-254 Single Agent
  • Drug: TLN-254
    TLN-254 will be administered orally at a specified dose on specified days.

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Molly Dubois, Sr. Clinical Research Coordinator
314-273-1486
amalia@wustl.edu

More Details

NCT ID
NCT06733441
Status
Recruiting
Sponsor
Treeline Biosciences, Inc.

Study Contact

Treeline Clinical Operations
857-228-0050
clinicaloperations@treeline.bio