NCT07297667

GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours

A Phase I Study of GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Participants With Selected Relapsed/Refractory GPNMB-Expressing Solid Tumours

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

Only enrolling in Canada. The purpose of this study is to identify the highest dose of GCAR1, a chimeric antigen receptor (CAR-T) cell therapy, that can be tolerated without causing very severe side effects, and to see what effects GCAR1 has on selected cancers

Detailed description

GCAR1 is a type of CAR-T cell therapy that is designed to identify a protein (GPNMB) that is present on the cells of certain types of cancer. Laboratory tests have shown that GCAR1 helps the immune system recognize cancer cells and may help slow down cancer growth. The purpose of this study is to find out what effects the new treatment, GCAR1 has on certain cancers. This study will test increasing doses of GCAR1 in participants with alveolar soft part sarcoma (ASPS), triple negative breast cancer (TNBC), and renal cell carcinoma (RCC) expressing high levels of the GPNMB protein, to establish recommended doses for further testing.

Conditions

• Alveolar Soft Part Sarcoma
• Renal Cell Carcinoma
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Fludarabine	Assigned at enrollment
DRUG	Cyclophosphamide	Assigned at enrollment
BIOLOGICAL	GCAR1	Dose escalation

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-12-01
• Completion: 2033-09-01
• First posted: 2025-12-22
• Last updated: 2026-04-13

Locations

3 sites across 1 country: Canada