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

PHASE1RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 6, 2022

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2027

Conditions
Pediatric Solid TumorOsteosarcomaRhabdomyosarcomaNeuroblastomaEwing SarcomaWilms TumorAdrenocortical CancerDesmoplastic Small Round Cell TumorGerm Cell CancerRhabdoid TumorClear Cell SarcomaHepatoblastomaMelanomaCarcinomaMalignant Peripheral Nerve Sheath TumorsSoft Tissue Sarcoma
Interventions
DRUG

Fludarabine

Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis. Intravenous

DRUG

Cyclophosphamide

Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA. Intravenous

DRUG

MESNA

Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide

DRUG

B7-H3 CAR T cells

The study participant will receive B7-H3-CAR T cells by vein, through either an IV or a central line.

Trial Locations (1)

38105

RECRUITING

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER