B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)

3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed/refractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors. Primary objective To determine the safety of one intravenous infusion of autologous, B

Trial Details

NCT ID
NCT04897321
Phase
PHASE1
Sponsor
St. Jude Children's Research Hospital
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Fludarabine
  • Cyclophosphamide
  • MESNA
  • B7-H3 CAR T cells
Locations (sample)
  • Memphis, Tennessee, United States|35.14953,-90.04898

Key Eligibility Criteria

  • Procurement and T-cell production eligibility\*
  • \*a previously collected, autologous leukapheresis product can be used for T-cell production
  • Age ≤21 years old
  • B7-H3+ solid tumor with measurable disease; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using a previously obtained b…

For full eligibility, visit ClinicalTrials.gov.

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