SPEARHEAD-3 Pediatric Study

Purpose

This is a pediatric basket study to investigate the safety and efficacy of afamitresgene autoleucel in HLA-A*02 eligible and MAGE-A4 positive subjects aged 2-17 years of age with advanced cancers.

Conditions

  • Synovial Sarcoma
  • Malignant Peripheral Nerve Sheath Tumor (MPNST)
  • Neuroblastoma (NBL)
  • Osteosarcoma

Eligibility

Eligible Ages
Between 2 Years and 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Subject has histologically confirmed diagnosis of any one of the following cancers: (A) Synovial Sarcoma (SS), (B) MPNST, (C) Neuroblastoma, or (D) Osteosarcoma (OS). - Age: (A) Synovial Sarcoma: 2 to 17 years (B) MPNST, Neuroblastoma and Osteosarcoma: 2 to 21 years - Body weight ≥ 10 kg - Must have previously received a systemic chemotherapy - Measurable disease prior to lymphodepletion according to RECIST v1.1 (or INCR, 2017 Neuroblastoma only). - HLA-A*02 positive - Tumor shows MAGE-A4 expression confirmed by central laboratory. - Performance Status: (A) Subjects ≥16: Eastern Cooperative Oncology Group (ECOG) 0 or 1 (B) Subjects 2 to 16: Lansky score ≥ 80 • Subject has anticipated life expectancy of greater than 3 months in the opinion of the investigator.

Exclusion Criteria

  • Positive for HLA-A*02:05 in either allele; or any A*02 having same protein sequence as HLA-A*02:05 - History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide. - History of autoimmune or immune mediated disease - Known central nervous system (CNS) metastases. - Other prior malignancy that is not considered by the Investigator to be in complete remission - Clinically significant cardiovascular disease - Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus - Pregnant or breastfeeding - Experiencing ongoing rapid disease progression that in the opinion of the Investigator significantly increases the subjects risk associated with treatment.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Afamitresgene autoleucel
  • Genetic: Afamitresgene autoleucel
    Single infusion of afamitresgene autoleucel Dose: For subjects ≥10 kg to <40 kg: starting dose of 0.025 - 0.200 x 10'9 transduced cells/kg. For subjects ≥40 kg 1.0x109 to 10x109 transduced by a single intravenous infusion

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University
St Louis 4407066, Missouri 4398678 63110
Contact:
Tina Primeau, BA
314-454-2147
tprimeau@wustl.edu

More Details

NCT ID
NCT05642455
Status
Recruiting
Sponsor
Adaptimmune