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

Early Phase 1

Completed

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

• Registration Number: NCT06827886
• Lead Sponsor: AHS Cancer Control Alberta

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-06
• Primary Completion: 2024-09-09
• Study Completion: 2024-09-09
• Status Verified: 2025-02
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

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

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.

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 safety of GCAR1	1 year	Treatment-Related Adverse Events to GCAR1 will be determined by monitoring participant for complications related to treatment using CTCAE v5.0.
Assess for anti-tumor activity	1 year	To assess for anti-tumor activity by measuring response of specified lesions. Response will be assessed by RECIST 1.1. Progression free survival (PFS) is calculated as the period from the day of starting administration of the study drug to the date that disease progression is confirmed by radiographic assessment. 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. If diagnostic imaging studies are performed at other times, either during or after treatment on this study, that data will be collected and information gained may be used to for further direction in the study of anti-GPNMB CAR T-cells, if appropriate consent is obtained.

Trial Locations

Locations (1)

Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre; 🇨🇦 Calgary, Canada