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New treatment option for Synovial Sarcoma
Official title SPEARHEAD-3 Pediatric Study
ClinicalTrials.gov ID: NCT05642455
What this study is testing
What is Afamitresgene autoleucel?
Afamitresgene autoleucel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for synovial sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 21
You may be able to join if
- Subject has histologically confirmed diagnosis of any one of the following cancers: (A) Synovial Sarcoma (SS), (B) MPNST, (C) Neuroblastoma, or (D)...
- 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).
You likely can't join 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
See the full eligibility 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) people ≥16: Eastern Cooperative Oncology Group (ECOG) 0 or 1 (B) people 2 to 16: Lansky score ≥ 80
- Subject has anticipated life expectancy of greater than 3 months in the opinion of the investigator.
- 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 people risk associated with treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Seattle, Washington, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Bethesda, Maryland, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; New York, New York, United States; Durham, North Carolina, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.