GPNMB-targeting Chimeric Antigen Receptor T-Cell Therapy (GCAR1) for a Patient with Alveolar Soft Part Sarcoma (CLIC-YYC-GPNMB-02)

Early Phase 1

Not yet recruiting

• Conditions: Alveolar Soft Part Sarcoma
• Interventions: Biological: GCAR1

• Registration Number: NCT06789081
• Lead Sponsor: AHS Cancer Control Alberta

Brief Summary

CLIC-YYC-GPNMB-02 is a Single Patient Study (SPS) developed according to the Health Canada template and guidelines released in 2019 for studies to access therapies not otherwise available to patients, in the situation where there are no options of treatment or cure remaining. The patient under consideration for CLIC-YYC-GPNMB-02 has progressive metastatic alveolar soft part sarcoma (ASPS). We propose to treat the patient with 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23
• Study Start: 2025-04-30
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GCAR1	GCAR1	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)

Primary Outcome Measures

Name	Time	Method
Assess for anti-tumor activity	1 year	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.