NCT06500819

Autologous B7-H3 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Solid Tumors

Phase I Clinical Trial of Autologous B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Children and Young Adults With Relapsed or Refractory Solid Tumor Expressing B7-H3 Target

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Crystal Mackall, MD · Academic / Other
• Sex: All
• Age: 2 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the manufacturing feasibility and safety of intravenous (IV) administration of B7-H3CART in children and young adult subjects with relapsed and/or refractory solid tumors expressing B7-H3 target using a standard 3+3 dose escalation design.

Conditions

• Neuroblastoma
• Sarcoma
• Osteosarcoma

Interventions

Type	Name	Description
DRUG	B7-H3CART Dose (Intravenous)	Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level -1 (DL-1) 0.3 x 106 transduced T cells/kg Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level 1 (DL1) 1 x 106 transduced T cells/kg Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level 2 (DL2) 3 x 106 transduced T cells/kg Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level 2 (DL2) 3 x 106 transduced T cells/kg Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level 3 (DL3) 9 x 106 transduced T cells/kg

Timeline

• Start date: 2024-07-11
• Primary completion: 2029-07-01
• Completion: 2029-07-01
• First posted: 2024-07-15
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study