SPEARHEAD-3 Pediatric Study

Not Recruiting

Trial ID: NCT05642455


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 2-21 years of age with advanced cancers

Official Title

A Phase 1/2 Open Label, Basket Study to Assess the Safety, Tolerability and Anti-Tumor Activity of Afamitresgene Autoleucel in Pediatric Subjects With MAGE-A4 Positive Tumors

Stanford Investigator(s)


Inclusion Criteria:

   - Age 2-21 years

   - Body weight ≥ 10 kg

   - Subject has histologically confirmed diagnosis of any one of the following cancers:
   (A) Synovial Sarcoma, (B) MPNST, (C) Neuroblastoma, or (D) Osteosarcoma

   - Must have previously received a systemic chemotherapy

   - Measurable disease 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: ECOG 0-1 or Lansky Score ≥ 80

Exclusion Criteria:

   - 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

   - 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


genetic: Afamitresgene autoleucel

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305