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GCAR1 · 2 trials · 1 indication
Response is the primary endpoint of this study. Diagnostic imaging (CT and/or MRI) will be performed pre-infusion to document measurable disease, and 4-6 weeks after GCAR1 T-cell infusion to evaluate response to therapy.
Treatment-Related Adverse Events to GCAR1 will be determined by monitoring participant for complications related to treatment using CTCAE v5.0.
| Arm | Type | Description |
|---|---|---|
| GCAR1 | EXPERIMENTAL | GCAR1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB) |
| Name | Type | Description |
|---|---|---|
| GCAR1 | BIOLOGICAL | GCAR 1 is a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB). |
Inclusion Criteria: * Completion of Informed Consent Form * Adequate organ function, defined as creatinine clearance \>30 ml/min and LVEF \>45%. Exclusion Criteria: * Any active uncontrolled infection, pregnancy or nursing.
GCAR1 is an investigational chimeric antigen receptor T-cell therapy being studied for the treatment of Alveolar Soft Part Sarcoma, a rare type of soft tissue cancer. It is currently in early Phase 1 clinical development and has not been approved by regulatory authorities.
GCAR1 targets GPNMB, a protein expressed on the surface of certain tumor cells. By engineering a patient's T cells to recognize GPNMB, the therapy aims to direct the immune system to attack cancer cells that display this protein.
GCAR1 is being developed by Avalon GloboCare Corp., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol ALBT.
GCAR1 is in early Phase 1 clinical development. It is an investigational therapy that has not yet received regulatory approval. The ongoing clinical trials are designed to evaluate its safety and feasibility in patients with Alveolar Soft Part Sarcoma.
GCAR1 is being studied in two early Phase 1 clinical trials in Canada. One trial, NCT06789081, is active but not recruiting, while the other, NCT06827886, has been completed. Each trial enrolls one adult patient with Alveolar Soft Part Sarcoma.
Yes, GCAR1 is a GPNMB-targeting chimeric antigen receptor T-cell therapy. The clinical trial titles describe it as GPNMB-targeting Chimeric Antigen Receptor T-Cell Therapy, which is the same investigational product being evaluated for Alveolar Soft Part Sarcoma.