SPEARHEAD-3 Pediatric Study
Sponsor: Adaptimmune
Sponsor score: 60
ClinicalTrials ID:NCT05642455
The SPEARHEAD-3 Pediatric Study evaluates the safety and efficacy of afamitresgene autoleucel in HLA-A*02 and MAGE-A4 positive subjects aged 2-21 with advanced cancers. Eligible participants must weigh ≥10 kg, have specific cancer types, prior chemotherapy, measurable disease, and good performance status. The intervention involves a single infusion of transduced cells, with dosage based on body weight.
Patient Parameters
| Parameter | Options |
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Program Overview
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
Eligibility Criteria
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Stanford University | 94305 | Palo Alto | California |
| University of Colorado | 80045, | Aurora | Colorado |
| National Institutes of Health | 20892 | Bethesda | Maryland |
| Dana Farber Cancer Institute | 10065 | Boston | Massachusetts |
| Washington University | 63110 | Saint Louis | Missouri |
| Memorial Sloan Kettering Kids | 10065 | New York | New York |
| Duke University School of Medicine | 27710 | Durham | North Carolina |
| Cincinnati Children's Hospital Medical Center | 45229 | Cincinnati | Ohio |
| Children's Hospital of Philedephia | 19104 | Philadelphia | Pennsylvania |
| Seattle Children's Hospital | 98105 | Seattle | Washington |
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