SPEARHEAD-3 Pediatric Study
Recruiting now · Phase 1/Phase 2
Conditions studied: Synovial Sarcoma, Malignant Peripheral Nerve Sheath Tumor (MPNST), Neuroblastoma (NBL), Osteosarcoma
In brief
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.
Key facts
- Study ID
- NCT05642455
- Run by
- USWM CT, LLC
- People needed
- 20
- Starts
- 2023-09-01
- Expected to finish
- 2038-07-30
- Last updated by the study team
- 2026-02-09
Who can join
Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Stanford University — Palo Alto, California, United States (enrolling)
- National Institutes of Health — Bethesda, Maryland, United States (enrolling)
- Washington University — St Louis, Missouri, United States (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- Children's Hospital of Philedephia — Philadelphia, Pennsylvania, United States (enrolling)
- University of Wisconsin Cancer Center — Madison, Wisconsin, United States (enrolling)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Seattle Children's Hospital — Seattle, Washington, United States
- Memorial Sloan Kettering Kids — New York, New York, United States
- Duke University School of Medicine — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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