NCT05627323

CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma

A Phase 1b Study to Evaluate CHM-1101, a CAR T-Cell Therapy With a Chlorotoxin Tumor-Targeting Domain for Patients With Matrix Metallopeptidase 2 Positive (MMP2+) Recurrent or Progressive Glioblastoma Multiforme

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Chimeric Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1b study to evaluate the safety of chimeric antigen receptor (CAR) T cells with a chlorotoxin tumor-targeting domain (ie, CHM-1101, the study treatment) to determine the best dose of CHM-1101, and to assess the effectiveness of CHM-1101 in treating MMP2+ glioblastoma that has come back (recurrent) or that is growing, spreading, or getting worse (progressive).

Detailed description

This is a phase 1b, multicenter, feasibility/safety study of the dual delivery (administered through both intracavitary/intratumoral \[ICT\] and intraventricular \[ICV\] catheters) of CHM-1101, an autologous chlorotoxin-chimeric antigen receptor (CLTX-CAR) cell product, in participants with recurrent or progressive GBM. The investigational product is identified as CHM-1101 (CLTX(EQ)28ζ/CD19t+ CAR T cells). PRIMARY OBJECTIVE • To determine the recommended phase 2 dose (RP2D) for dual ICT and ICV delivery of CHM-1101 in participants with MMP2+ recurrent or progressive GBM. SECONDARY OBJECTIVES * To assess the feasibility and safety of dual delivery of CHM-1101. * To describe the persistence, expansion, immunogenicity, and phenotype of CHM-1101 and endogenous cells tumor cyst fluid (TCF), peripheral blood (PB), and cerebrospinal fluid (CSF). * In participants who receive at least 2 of the 3 planned doses of CHM-1101 in Cycle 1: * Estimate the progression-free survival (PFS) rates * Estimate the overall survival (OS) rates * To evaluate the disease response rate.

Conditions

• Glioblastoma Multiforme of Brain

Interventions

Type	Name	Description
BIOLOGICAL	CHM-1101 CAR-T cells	Administered via ICT/ICV dual delivery

Timeline

• Start date: 2023-06-06
• Primary completion: 2026-12-01
• Completion: 2041-01-01
• First posted: 2022-11-25
• Last updated: 2026-01-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study