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
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Assigned at enrollment
Assigned at enrollment
Dose escalation
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
University Health Network Princess Margaret Hospital
Toronto, Ontario, Canada
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
(GCAR1) in participants with selected tumours (alveolar soft part sarcoma, renal cell carcinoma (excluding clear cell), triple negative breast cancer) expressing GPNMB
Time frame: 3 years
Number and severity of adverse eventsGCAR1 utilizing CTCAE v5.0
Time frame: 3 years
Overall response rate utilizing RECIST 1.1
Time frame: 3 years
Duration of response
Time frame: 3 years
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