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SPEARHEAD-3 Pediatric Study
Recruiting
Trial ID: NCT05642455
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 2-21 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)
Eligibility
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 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
Intervention(s):
genetic: Afamitresgene autoleucel
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305