Investigating afamitresgene autoleucel for pediatric cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pediatric basket study aims to evaluate the safety and efficacy of afamitresgene autoleucel in children and young adults aged 2-21 years who are HLA-A*02 eligible and MAGE-A4 positive, diagnosed with advanced cancers such as synovial sarcoma, malignant peripheral nerve sheath tumor, neuroblastoma, or osteosarcoma. Participants must have previously received systemic chemotherapy and have measurable disease. The study will assess the treatment's impact on these specific cancer types, focusing on the unique genetic markers present in the tumors.

Why it matters

Who can join: the full rules

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.

Where it's running

• Stanford University
  Palo Alto, California, United States Recruiting
• National Institutes of Health
  Bethesda, Maryland, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting
• Memorial Sloan Kettering Kids
  New York, New York, United States Recruiting
• Duke University School of Medicine
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Fiorella Iglesias Cardenas, MD — Memorial Sloan Kettering Kids

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.