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CLIC-YYC-GPNMB-01 is a Single Patient Study (SPS) developed according to the Health Canada template and guidelines released in 2019 for studies to access therapies not otherwise available to patients, in the situation where there are no options of treatment or cure remaining. The patient under consideration for CLIC-YYC-GPNMB-01 has progressive metastatic alveolar soft part sarcoma (ASPS). The investigators propose to treat the patient with GCAR1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GCAR1 | Experimental | GCAR1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GCAR1 | Biological | GCAR 1 is a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB). |
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety of GCAR1 | Treatment-Related Adverse Events to GCAR1 will be determined by monitoring participant for complications related to treatment using CTCAE v5.0. | 1 year |
| Assess for anti-tumor activity | To assess for anti-tumor activity by measuring response of specified lesions. Response will be assessed by RECIST 1.1. Progression free survival (PFS) is calculated as the period from the day of starting administration of the study drug to the date that disease progression is confirmed by radiographic assessment. Diagnostic imaging (CT and/or MRI) will be performed pre-infusion to document measurable disease, and 4-6 weeks after GCAR1 T-cell infusion to evaluate response to therapy. If diagnostic imaging studies are performed at other times, either during or after treatment on this study, that data will be collected and information gained may be used to for further direction in the study of anti-GPNMB CAR T-cells, if appropriate consent is obtained. | 1 year |
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Inclusion Criteria:
1. Completion of Informed Consent Form
Exclusion Criteria:
1. Any significant medical issue(s) that would, in the opinion of the Principal Investigator (PI), prevent this patient from being dosed.
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| Name | Affiliation | Role |
|---|---|---|
| Mona Shafey, MD, FRCPC | Alberta Health services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre | Calgary | Canada |
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| ID | Term |
|---|---|
| D018234 | Sarcoma, Alveolar Soft Part |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Single Patient Study (SPS)
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| D012509 | Sarcoma |