SPEARHEAD-3 Pediatric Study

Launched by ADAPTIMMUNE · Dec 6, 2022

Keywords

ClinConnect Summary

The SPEARHEAD-3 Pediatric Study is a clinical trial looking at a new treatment called afamitresgene autoleucel for children and young adults aged 2 to 21 years who have advanced cancers, specifically synovial sarcoma, malignant peripheral nerve sheath tumor (MPNST), neuroblastoma, or osteosarcoma. This study is designed to find out how safe and effective this treatment is for patients who have certain genetic markers (HLA-A*02 and MAGE-A4 positive) and have already received chemotherapy.

To be eligible for this trial, participants must weigh at least 10 kg and have a confirmed diagnosis of one of the specified cancers. They should also be in relatively good health, with a performance status that indicates they can handle treatment. Participants will receive the new treatment and will be closely monitored throughout the study. It's important to note that some individuals may not qualify if they have specific health issues, such as certain allergies, autoimmune diseases, or active infections. This trial is currently recruiting participants, offering an opportunity for young patients to potentially access an innovative therapy.

Gender

ALL

Eligibility criteria

• 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 ≥ 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.
• 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.