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ACTIVE NOT RECRUITING
NCT06813417
EARLY_PHASE1

CAR T Therapy With GCAR1 for Relapsed Alveolar Soft Part Sarcoma

Sponsor: University of Calgary

View on ClinicalTrials.gov

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.

Official title: An Open Label Individual Patient Dose Escalation Study Investigating the Safety and Efficacy of Retreatment With GCAR1 in a Patient With Multiply Relapsed Alveolar Soft Part Sarcoma

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

1

Start Date

2025-01-30

Completion Date

2030-01-30

Last Updated

2025-04-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

GCAR1

GCAR1 is a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector encoding a chimeric antigen receptor (CAR) targeting GPNMB. The CAR comprises a single-chain variable fragment (scFv) binding domain derived from a fully human GPNMB-specific monoclonal antibody (CDX-011), a CD8 hinge and transmembrane domain, and the CD137 (4-1BB) and CD3 zeta chain intracellular signaling domains. Following infusion, the autologous GPNMB CAR T-cells expressing the genetically engineered anti-GPNMB CAR enable the specific targeting of GPNMB-expressing cells. Upon binding to GPNMB-expressing cells, the CAR transmits T cell activation signals that promote the elimination of target cells through CAR T cell degranulation and the release of cytotoxic molecules. The cellular signal also facilitates CAR T cell proliferation and persistence that may enable prolonged disease control through immunosurveillance3.

Locations (1)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada