Recruiting

GCAR1 CAR-T Cell Therapy for GPNMB-Expressing Solid Tumours

Study Aim

This study aims to determine the recommended dose for phase II of GCAR1 CAR-T cell therapy in patients with selected GPNMB-expressing solid tumours, such as alveolar soft part sarcoma, renal cell carcinoma (excluding clear cell), and triple negative breast cancer.

What is being tested

Fludarabine

+ Cyclophosphamide

+ GCAR1

DrugBiological

Who is being recruted

Urogenital Diseases+22

+ Adenocarcinoma

+ Breast Diseases

Over 15 Years

+27 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: June 2026

See protocol details

Summary

Principal SponsorCanadian Cancer Trials Group

Study ContactLaura PearceMore contacts

Last updated: July 14, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 30, 2026

Actual date on which the first participant was enrolled.

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.

NCT07297667

Principal SponsorCanadian Cancer Trials Group

Study ContactLaura PearceMore contacts

Last updated: July 14, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 15 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAdenocarcinomaBreast DiseasesBreast NeoplasmsCarcinomaFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialNeoplasms, Muscle TissueSarcomaSkin DiseasesUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsSkin and Connective Tissue DiseasesNeoplasms, Connective and Soft TissueFemale Urogenital DiseasesMale Urogenital DiseasesCarcinoma, Renal CellSarcoma, Alveolar Soft PartTriple Negative Breast Neoplasms

Criteria

17 inclusion criteria required to participate

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 - 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). ≤3 lines of treatment for metastatic disease. 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).

Anticipated life expectancy of ≥ 6 months.

ASPS participants ≥ 15 years of age.

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)

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10 exclusion criteria prevent from participating

Prior therapy with a gene therapy product or any adoptive T cell therapy or prior GPNMB targeting therapy.

Concurrent treatment with other anti-cancer therapy

Pregnant or breastfeeding women.

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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, CanadaOpen Arthur J.E. Child Comprehensive Cancer Centre in Google Maps

Recruiting soon

University Health Network

Toronto, Canada

Recruiting

2 Study Centers