Afamitresgene Autoleucel in Pediatric Subjects with MAGE-A4 Positive Tumors

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This study involves an investigational cellular therapy called Afamitresgene Autoleucel. The overall goal of this study is to find out how safe and effective this cellular therapy is in treating people that have been diagnosed with synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST), neuroblastoma or osteosarcoma that has grown or returned after being treated.

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at CancerTrials [at] chop.edu or 267-425-5544.

ClinicalTrials.gov Identifier

NCT05642455

View full trial information on ClinicalTrials.gov

Eligibility & Criteria

IRB #:
23-021613
Official Title:
A Phase 1/2, Open-Label, Basket Study to Assess the Safety, Tolerability, and Anti- Tumor Activity of Afamitresgene Autoleucel in Pediatric Subjects with MAGE-A4 Positive Tumors
Study Phase:
Phase I
Phase II
Eligible Age Range:
2 - 21 Years
Gender:
All
Study Categories:

Visit Criteria

The study will enroll male and female patients between 2 and 21 years of age that have been diagnosed with synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST), neuroblastoma or osteosarcoma that has grown or returned after being treated.
As a participant in this research, you will:

  • Undergo leukapheresis to remove white blood cells (called T Cells) from your blood
  • Receive the cellular therapy called Afamitresgene Autoleucel via infusion. This is manufactured from your T Cells.
  • Complete frequent clinic visits at CHOP
  • Have research blood tests
  • Have extra or leftover tissue collected if you have a biopsy as part of your regular cancer care
  • Have periodic imaging performed as part of your regular cancer care to evaluate your response to treatment
Leader
Aashim Bhatia

Aashim Bhatia, MD, MS