CAR T Therapy With GCAR1 for Relapsed Alveolar Soft Part Sarcoma

Early Phase 1

Active, not recruiting

• Conditions: Sarcoma; Alveolar Soft Part Sarcoma (ASPS)
• Interventions: Biological: GCAR1

• Registration Number: NCT06813417
• Lead Sponsor: University of Calgary

Brief Summary

A single patient study to determine whether GCAR1 is safe and effective for re-treatment of alveolar soft part sarcoma (ASPS) with GPNMB surface expression that has relapsed and is not responding to usual treatment.

Detailed Description

CLIC-YYC-GPNMB-04 is an Open Label Individual Patient (OLIP)/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-04 has refractory, progressive metastatic alveolar soft part sarcoma (ASPS). There are no standard therapies for relapsed ASPS known to provide potential for cure, and there are no clinical trials available in Canada for consideration. We propose to re-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). The patient was previously treated with GCAR1 under CLIC-YYC-GPNMB-01 (c#276646).

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-28
• Study Start: 2025-01-30
• Study First Submitted QC: 2025-02-05
• Study First Posted: 2025-02-07
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2030-01-30
• Study Completion: 2030-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

• The patient must provide informed consent
• Adequate organ function, defined as creatinine clearance >30 ml/min and LVEF >45%

Exclusion Criteria

• Any active uncontrolled infection
• Pregnancy or nursing
• Anti-cancer therapy within 21 calendar days prior to the first dose of lymphodepleting chemotherapy. If subject has received anti-cancer therapy, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy as per the discretion of the Qualified Investigator/Co-Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GCAR1	GCAR1	This is an intrapatient two-dose escalation study. The patient will receive two separate intravenous infusions of cryopreserved, autologous GCAR1, with at least three months (+/- 30 days) between infusions. Both infusions will be preceded by standard lymphodepleting chemotherapy (Fludarabine 40 mg/m2 x 3 days, cyclophosphamide 600 mg/m2 x 2 days) . Dose 1 will be 5.0E6 CAR+ T cells/kg patient body weight, Dose 2 will be 2.5E7 CAR+ T cells/kg patient body weight. Infusions will be intravenous, single infusions.

Primary Outcome Measures

Name	Time	Method
Treatment Response	Diagnostic imaging (CT and/or MRI) will be performed at baseline (pre-treatment) and then subsequently at 4-6 weeks after GCAR1 infusion, and at 3 months, 6 months, 9 months and 1 year after last infusion to evaluate response to therapy.	The overall response assessment considers the response of the target and non-target lesions and development of new lesions.; Response Classification of Target Lesions, CNS lesions and Non-Target Lesions; * Complete response (CR): * Partial response (PR): * Progressive disease (PD): * Stable disease (SD):

Trial Locations

Locations (1)

Arthur J.E. Child Comprehensive Cancer Centre; 🇨🇦 Calgary, Alberta, Canada