GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours

May 11, 2026 updated by: Canadian Cancer Trials Group

A Phase I Study of GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Participants With Selected Relapsed/Refractory GPNMB-Expressing Solid Tumours

Only enrolling in Canada.

The purpose of this study is to identify the highest dose of GCAR1, a chimeric antigen receptor (CAR-T) cell therapy, that can be tolerated without causing very severe side effects, and to see what effects GCAR1 has on selected cancers

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

GCAR1 is a type of CAR-T cell therapy that is designed to identify a protein (GPNMB) that is present on the cells of certain types of cancer. Laboratory tests have shown that GCAR1 helps the immune system recognize cancer cells and may help slow down cancer growth.

The purpose of this study is to find out what effects the new treatment, GCAR1 has on certain cancers. This study will test increasing doses of GCAR1 in participants with alveolar soft part sarcoma (ASPS), triple negative breast cancer (TNBC), and renal cell carcinoma (RCC) expressing high levels of the GPNMB protein, to establish recommended doses for further testing.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J.E. Child Comprehensive Cancer Centre
        • Contact:
          • Mona Shafey
          • Phone Number: 403 944-8047

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Archival tumour specimen must be positive for GPNMB with high expression by immunohistochemistry (central laboratory testing).
  • Histologically and/or cytologically confirmed diagnosis of one of the following tumours that is advanced/ metastatic/ recurrent or unresectable, for which no curative therapy exists.
  • alveolar soft part sarcoma
  • renal cell carcinoma (excluding clear cell)
  • triple negative breast cancer (ER, PR and HER-2 negative as defined by ASCO/CAP criteria)
  • Must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block.
  • Presence of radiologically documented disease.
  • Measurable disease as defined by RECIST 1.1.
  • ASPS participants ≥ 15 years of age.
  • TNBC and RCC participants ≥ 18 years of age.
  • ECOG performance status of 0 or 1 or Karnofsky or Lansky > 60.
  • Anticipated life expectancy of ≥ 6 months.
  • Must have received prior systemic therapy as shown below;
  • ASPS - completed all systemic therapy available that has been shown to improve survival (unless contraindicated).

  • TNBC

    1. Progressive disease following at least one line of systemic treatment for metastatic disease which must include an ADC (all participants) and an ICI (participants whose tumours express PD-L1).
    2. ≤3 lines of treatment for metastatic disease.
    3. Must have had at least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, which must have included an anthracycline and a taxane (unless contraindicated).
  • RCC - must have progressive disease following at least one line of systemic treatment for metastatic disease that must have included an ICI and a VEGFR targeted agent (unless contraindicated).
  • Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies.
  • Adequate washout must be followed per protocol.
  • Previous major surgery is permitted ≥21 days prior to enrollment
  • Prior external beam radiation is permitted ≥28 prior to enrollment. Concurrent radiotherapy is not permitted.
  • Adequate hematologic and biochemical parameters.
  • Consent and assent, when applicable, must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant or their parent/ legal guardian (if applicable) must sign a consent form prior to screening onto the trial to document their willingness to participate.
  • Fit for leukapheresis and has adequate venous access for cell collection.
  • Must be accessible for treatment and follow up at the participating centre for a minimum of 12 months or for as long as is deemed necessary by the treating physician.
  • Participants of childbearing potential must have agreed to use a highly effective contraceptive method.

Exclusion criteria

  • Participants on active anticancer therapy for other advanced or metastatic malignancies.
  • Concurrent treatment with other anti-cancer therapy
  • Prior therapy with a gene therapy product or any adoptive T cell therapy or prior GPNMB targeting therapy.
  • Live attenuated vaccination administered within 30 days prior to or planned within 30 days after GCAR1 therapy.
  • Primary immunodeficiency or history of severe autoimmune disease (including: Crohn's disease, rheumatoid arthritis, systemic lupus) requiring immunosuppressive agents/ systemic disease modifying agents within 2 years of enrollment.
  • Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol including but not limited to:
  • Hepatitis B or C virus (HBV or HCV). For participants with previous HBV or HCV infection who are currently on treatment, they are eligible if they have an undetectable viral load via quantitative PCR and/or nucleic acid testing
  • HIV positive by serology and PCR
  • Uncontrolled fungal, bacterial, viral or other infection
  • Current infection with HTLV-1
  • Tuberculosis
  • Syphilis
  • West Nile Virus
  • Untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction (including cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) or unstable angina congestive heart failure or myocardial infarction within the previous year.
  • Known sensitivity or allergy to fludarabine, cyclophosphamide or any of their components, or to GCAR1 or any of its components.
  • Active intracerebral metastases or leptomeningeal disease. Participants who have received definitive treatment, are clinically stable and do not require corticosteroids are eligible to participate in the trial.
  • Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GCAR1 Infusion
Drug: Fludarabine
Assigned at enrollment
Drug: Cyclophosphamide
Assigned at enrollment
Biological: GCAR1
Dose escalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the recommended phase II dose (RP2D), defined as the next lower dose below the maximum administered dose, of GPNMB directed CAR T cell therapy
Time Frame: 3 years
(GCAR1) in participants with selected tumours (alveolar soft part sarcoma, renal cell carcinoma (excluding clear cell), triple negative breast cancer) expressing GPNMB
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of response
Time Frame: 3 years
3 years
Number and severity of adverse eventsGCAR1 utilizing CTCAE v5.0
Time Frame: 3 years
3 years
Overall response rate utilizing RECIST 1.1
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Cancer Trials Group

Collaborators

Canadian Institutes of Health Research (CIHR)
University of Calgary
BioCanRx

Investigators

  • Study Chair: Mona Shafey, Tom Baker Cancer Centre, Calgary, Alberta, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

September 1, 2033

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

According to CCTG Policies

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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