Actively Recruiting
A Phase I Study of GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Participants With Selected Relapsed/Refractory GPNMB-Expressing Solid Tumours
Led by Canadian Cancer Trials Group · Updated on 2026-06-08
30
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
C
Canadian Cancer Trials Group
Lead Sponsor
U
University of Calgary
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying GCAR1, a chimeric antigen receptor (CAR) T-cell therapy, in participants with relapsed or refractory solid tumors that express high levels of the GPNMB protein. This includes cancers such as alveolar soft part sarcoma (ASPS), triple negative breast cancer (TNBC), and renal cell carcinoma (RCC). The study aims to find the highest dose of GCAR1 that can be tolerated without severe side effects and to observe its effects on these cancers. The study involves dose escalation of GCAR1, combined with drugs fludarabine and cyclophosphamide, which are assigned at enrollment. Participants receive GCAR1 infusions at increasing doses to determine the recommended phase II dose. The trial focuses on participants with advanced or metastatic tumors with high GPNMB expression. Treatment includes leukapheresis for cell collection and requires adequate venous access. Participants must be accessible for treatment and follow-up for at least 12 months. During the study, researchers will monitor safety by recording adverse events and assessing cancer response using RECIST 1.1 criteria. They will also track the duration of response to treatment. Participants undergo evaluations including tumor tissue testing, imaging to confirm measurable disease, and regular clinical assessments. The main outcome is to establish the recommended dose for future studies over a three-year observation period. Safety and response will be closely followed throughout the trial.
CONDITIONS
Brief Title
GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Archival tumor specimen positive for high GPNMB expression by immunohistochemistry
- Confirmed diagnosis of alveolar soft part sarcoma, renal cell carcinoma (excluding clear cell), or triple negative breast cancer
- Formalin fixed paraffin embedded tissue block available and consented for release
- Radiologically documented measurable disease by RECIST 1.1
- Age 15 years or older for ASPS; 18 years or older for TNBC and RCC
- ECOG performance status 0 or 1 or Karnofsky/Lansky score above 60
- Life expectancy of 6 months or more
- Prior systemic therapy as specified per tumor type
- Recovery to grade 1 or less from prior therapy toxicities
- Adequate washout period followed
- Major surgery at least 21 days prior to enrollment
- Prior external beam radiation at least 28 days prior; no concurrent radiotherapy
- Adequate blood and biochemical test results
- Consent and assent obtained as appropriate
- Fit for leukapheresis and adequate venous access
- Accessible for treatment and follow-up for at least 12 months
- Agreed to use highly effective contraception if of childbearing potential
You will not qualify if you...
- Active anticancer therapy for other advanced or metastatic cancers
- Concurrent treatment with other anticancer therapies
- Previous gene therapy, adoptive T cell therapy, or GPNMB targeting therapy
- Live attenuated vaccination within 30 days before or after GCAR1 therapy
- Primary immunodeficiency or severe autoimmune disease requiring immunosuppressants within 2 years
- Active or uncontrolled infections including hepatitis B or C unless undetectable viral load
- HIV positive
- Current infection with HTLV-1, tuberculosis, syphilis, or West Nile Virus
- Untreated or uncontrolled cardiovascular issues or recent cardiac events
- Known allergy to fludarabine, cyclophosphamide, GCAR1, or their components
- Active brain metastases or leptomeningeal disease unless stable and not needing corticosteroids
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Short period before GCAR1 infusion
Participants receive preparatory treatment with fludarabine and cyclophosphamide before the CAR T-cell therapy.
Visits as needed for drug administration
Duration - Up to several weeks depending on dosing schedule
Participants receive dose-escalation treatment with GCAR1 CAR T-cell therapy to assess safety and determine the recommended dose.
1 baseline visit and multiple follow-up visits during dosing
Duration - Up to 3 years
Participants are monitored for safety, adverse events, and response to treatment after completing GCAR1 therapy.
Regular visits for up to 3 years
Trial Site Locations
Total: 1 location
1
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
Research Team
L
Laura Pearce
M
Mariam Jafri
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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