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SPEARHEAD-3 Pediatric Study

RecruitingPhase 1, Phase 2Ages 2 Years - 21 YearsAllUSWM CT, LLC
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 โ‰ฅ16: Eastern Cooperative Oncology Group (ECOG) 0 or 1 (B) Subjects 2 to 16: Lansky score โ‰ฅ 80 โ€ข 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.
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What it tests

  • Afamitresgene autoleucel
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Where

10 sites
Stanford University
Palo Alto, United States
National Institutes of Health
Bethesda, United States
Dana Farber Cancer Institute
Boston, United States
Washington University
St Louis, United States
Memorial Sloan Kettering Kids
New York, United States
Duke University School of Medicine
Durham, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, United States
Children's Hospital of Philedephia
Philadelphia, United States

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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