B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Carcinoma
- Adrenocortical Cancer
- Wilm's Tumor
- Clear Cell Sarcoma
- Desmoplastic Small Round Cell Tumor
- Ewing Sarcoma
- Germ Cell Cancer
- Soft Tissue Sarcoma
- Hepatoblastoma
- Malignant Peripheral Nerve Sheath Tumors
- Melanoma
- Rhabdomyosarcoma
- Neuroblastoma
- Pediatric Solid Tumor
- Rhabdoid Tumor
- Osteosarcoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 21 years
- Gender
- Both males and females
Description
Treatment will include a single infusion of B7-H3-CAR T cells after lymphodepleting chemotherapy, with dosing based on the number of CAR+ T cells and patient weight. The study will evaluate the safety and maximum tolerated dose (MTD) of B7-H3-CAR T cells, using a standard 3+3 study design and a 6-we...
Treatment will include a single infusion of B7-H3-CAR T cells after lymphodepleting chemotherapy, with dosing based on the number of CAR+ T cells and patient weight. The study will evaluate the safety and maximum tolerated dose (MTD) of B7-H3-CAR T cells, using a standard 3+3 study design and a 6-week evaluation period. The total study duration will be 1 year, at which point patients will enroll on our existing institutional long-term follow-up protocol.
Tracking Information
- NCT #
- NCT04897321
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Chris DeRenzo, MD St. Jude Children's Research Hospital
Get Well Soon