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

NCT06827886 | Completed Early Phase 1

• 1 other identifier: CLIC-YYC-GPNMB-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Assess safety of GCAR1

  Treatment-Related Adverse Events to GCAR1 will be determined by monitoring participant for complications related to treatment using CTCAE v5.0.

  1 year

• Assess for anti-tumor activity

  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.

  1 year

Study Arms (1)

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)

Biological: GCAR1

Interventions

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).

GCAR1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Completion of Informed Consent Form

You may not qualify if:

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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

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

Calgary, Canada

Location

MeSH Terms

Conditions

Sarcoma, Alveolar Soft Part

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Mona Shafey, MD, FRCPC

  Alberta Health services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Patient Study (SPS)

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 14, 2025
• Study Start: September 6, 2023
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)