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

Melanoma Clinical Trial

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

Clinical Trial Summary

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, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent/refractory B7-H3+ solid tumors after lymphodepleting chemotherapy Secondary objective To evaluate the antitumor activity of B7-H3-CAR T cells Exploratory objectives - To evaluate the tumor environment after treatment with B7-H3-CAR T cells - To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells - To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells

Clinical Trial 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-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. ;

Study Design

Related Conditions & MeSH terms

  • Adrenal Cortex Neoplasms
  • Adrenocortical Cancer
  • Adrenocortical Carcinoma
  • Carcinoma
  • Clear Cell Sarcoma
  • Desmoplastic Small Round Cell Tumor
  • Ewing Sarcoma
  • Germ Cell Cancer
  • Hepatoblastoma
  • Malignant Peripheral Nerve Sheath Tumors
  • Melanoma
  • Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Nerve Sheath Neoplasms
  • Neuroblastoma
  • Osteosarcoma
  • Pediatric Solid Tumor
  • Rhabdoid Tumor
  • Rhabdomyosarcoma
  • Sarcoma
  • Sarcoma, Clear Cell
  • Sarcoma, Ewing
  • Soft Tissue Sarcoma
  • Wilms Tumor
Clinical Trial Details
NCT number NCT04897321
Study type Interventional
Source St. Jude Children's Research Hospital
Contact Chris DeRenzo, MD
Phone 866-278-5833
Email referralinfo@stjude.org
Status Recruiting
Phase Phase 1
Start date July 6, 2022
Completion date March 1, 2027
View Details
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