GCAR1 / Alberta Health Services, Canadian Cancer Trials Group - LARVOL DELTA

GPNMB-directed CAR T cell therapy against MiT/TFE-family fusion-driven solid tumors. (PubMed, Nat Cancer) - P1 | "Spatial transcriptomics identified immunosuppressive niches in a treatment-resistant lesion and immune checkpoint blockade synergized with GCAR1 in a xenograft model. Altogether, our data provide a proof of concept for treating GPNMB-expressing solid tumors with GCAR1 and more broadly targeting surface antigens driven by oncogenic gene fusions with CAR T cell therapies."

First-in-human • Journal • Alveolar Soft Tissue Sarcoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor • GPNMB

CLIC-YYC-GPNMB: A Study to Determine the Safety and Effectiveness of the Investigational Cellular Therapy GCAR1 in a Patient With Alveolar Soft Part Sarcoma (clinicaltrials.gov) - P1 | N=1 | Active, not recruiting | Sponsor: University of Calgary | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Alveolar Soft Tissue Sarcoma • Oncology • Sarcoma • Solid Tumor

GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Canadian Cancer Trials Group | Not yet recruiting ➔ Recruiting

Enrollment open • Alveolar Soft Tissue Sarcoma • Breast Cancer • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • GPNMB • HER-2 • PD-L1 • PGR

GPNMB-targeting Chimeric Antigen Receptor T-Cell Therapy (GCAR1) for a Patient With Alveolar Soft Part Sarcoma (CLIC-YYC-GPNMB-02) (clinicaltrials.gov) - P1 | N=1 | Active, not recruiting | Sponsor: AHS Cancer Control Alberta | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Jan 2027 ➔ Mar 2028 | Trial primary completion date: Jan 2027 ➔ Mar 2028

Enrollment closed • Trial completion date • Trial primary completion date • Alveolar Soft Tissue Sarcoma • Oncology • Sarcoma • Solid Tumor

GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Canadian Cancer Trials Group | Trial completion date: Jun 2029 ➔ Sep 2033

Trial completion date • Alveolar Soft Tissue Sarcoma • Breast Cancer • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • GPNMB • HER-2 • PD-L1 • PGR

GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Canadian Cancer Trials Group

New P1 trial • Alveolar Soft Tissue Sarcoma • Breast Cancer • Genito-urinary Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Triple Negative Breast Cancer