GCAR1 / Alveolar Soft Part Sarcoma / Renal Cell Carcinoma · Phase 1 Trial

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

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 clinical trial registry record with no results yet posted. The study is designed to identify the recommended Phase 2 dose and safety profile of GCAR1, a GPNMB-directed CAR-T cell therapy, in patients with selected relapsed/refractory solid tumours. No efficacy or safety data are available from this registry record.

What was studied

Phase 1, Interventional, Single Group, Open label, Treatment purpose. Alveolar Soft Part Sarcoma, Renal Cell Carcinoma, Triple Negative Breast Cancer; age from 15 Years. Intervention: GCAR1 Infusion. n = 30. 2 sites: Canada.

Key findings

Safety

Phase 1 design limits inference to safety and tolerability; efficacy data not yet available

Who this may help

Clinicians should not draw any clinical conclusions from this registry record. The trial is still recruiting and has not yet reported safety, tolerability, or efficacy data. Results from this Phase 1 study will inform dose selection for future Phase 2 trials.

Plain-language summary

Phase 1 dose-escalation trial in early recruitment with no results reported; designed to establish safety and tolerability in a small population with relapsed/refractory solid tumours.

Study design

As stated by the source record.

MethodsPrimary outcome measure: 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 (assessed at 3 years)

DesignPhase 1, Interventional, Single Group, Open label, Treatment purpose

PopulationAlveolar Soft Part Sarcoma, Renal Cell Carcinoma, Triple Negative Breast Cancer; age from 15 Years

Sample size30

InterventionGCAR1 Infusion

Setting2 sites: Canada

Reported figures

Quoted from the source exactly as published.

Planned enrollment30

PhasePhase 1

Primary outcome measureRecommended phase II dose (RP2D) of GPNMB-directed CAR T cell therapy

Primary outcome follow-up duration3 years

Clinical bottom line

Caveats

No results have been posted in this registry record; study is still recruiting
Phase 1 design limits inference to safety and tolerability; efficacy data not yet available
Actual enrollment may differ from estimated 30 participants
No information on blinding, randomisation method, or statistical analysis plan provided in registry text

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Planned Phase 1 dose-escalation design with defined primary endpoint (RP2D)

Directness

strong

Direct evaluation of GCAR1 safety and tolerability in target patient populations

Consistency

insufficient

Registry record only; no results posted for comparison

Risk of bias

insufficient

Study design details insufficient to assess blinding, allocation concealment

Sample adequacy

limited

30 estimated participants typical for Phase 1 dose-escalation but underpowered for efficacy

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07297667). This is a study registration, not published results. Lead sponsor: Canadian Cancer Trials Group. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Alveolar Soft Part Sarcoma, Renal Cell Carcinoma, Triple Negative Breast Cancer. Interventions: DRUG: Fludarabine; DRUG: Cyclophosphamide; BIOLOGICAL: GCAR1. Primary outcome measures: 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 , 3 years. Brief summary: 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

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07297667GCAR1Alveolar Soft Part SarcomaCanadian Cancer Trials GroupRenal Cell CarcinomaTriple Negative Breast CancerCyclophosphamideFludarabine