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

Inclusion Criteria28

• 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)
• triple negative breast cancer (ER, PR and HER-2 negative as defined by ASCO/CAP criteria)
• Must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block.
• Presence of radiologically documented disease.
• Measurable disease as defined by RECIST 1.1.
• ASPS participants ≥ 15 years of age.
• TNBC and RCC participants ≥ 18 years of age.
• ECOG performance status of 0 or 1 or Karnofsky or Lansky > 60.
• Anticipated life expectancy of ≥ 6 months.
• Must have received prior systemic therapy as shown below;
• ASPS - completed all systemic therapy available that has been shown to improve survival (unless contraindicated).
• TNBC
• Progressive disease following at least one line of systemic treatment for metastatic disease which must include an ADC (all participants) and an ICI (participants whose tumours express PD-L1).
• ≤3 lines of treatment for metastatic disease.
• Must have had at least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, which must have included an anthracycline and a taxane (unless contraindicated).
• RCC - must have progressive disease following at least one line of systemic treatment for metastatic disease that must have included an ICI and a VEGFR targeted agent (unless contraindicated).
• Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies.
• Adequate washout must be followed per protocol.
• Previous major surgery is permitted ≥21 days prior to enrollment
• Prior external beam radiation is permitted ≥28 prior to enrollment. Concurrent radiotherapy is not permitted.
• Adequate hematologic and biochemical parameters.
• Consent and assent, when applicable, must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant or their parent/ legal guardian (if applicable) must sign a consent form prior to screening onto the trial to document their willingness to participate.
• Fit for leukapheresis and has adequate venous access for cell collection.
• Must be accessible for treatment and follow up at the participating centre for a minimum of 12 months or for as long as is deemed necessary by the treating physician.
• Participants of childbearing potential must have agreed to use a highly effective contraceptive method.