GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age15+
SponsorCanadian Cancer Trials Group
About this trial
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
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Fludarabine
- Cyclophosphamide
- GCAR1
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Canadian Cancer Trials Group
Lead sponsor
University of Calgary
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
BioCanRx
Collaborator
Source ClinicalTrials.gov