GPNMB-targeting Chimeric Antigen Receptor T-Cell Therapy (GCAR1) for a Patient With Alveolar Soft Part Sarcoma

NCT ID: NCT06827886

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-06
• Study Completion Date: 2024-09-09

Brief Summary

CLIC-YYC-GPNMB-01 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-01 has progressive metastatic alveolar soft part sarcoma (ASPS). The investigators 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).

Conditions

Alveolar Soft Part Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

GCAR1

Intervention Type: 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).

Interventions

GCAR1

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).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Completion of Informed Consent Form

Exclusion Criteria

1. Any significant medical issue(s) that would, in the opinion of the Principal Investigator (PI), prevent this patient from being dosed.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mona Shafey, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Alberta Health services

Locations

Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre

Calgary, , Canada

Countries

Canada

Other Identifiers

CLIC-YYC-GPNMB-01

Identifier Type: -

Identifier Source: org_study_id