Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06813417 | CAR T Therapy With GCAR1 for Relapsed Alveolar Soft Part Sarcoma | EARLY_PHASE1 | ACTIVE NOT_RECRUITING | 1 | — | — | Jan 30, 2025 | Jan 30, 2030 | Apr 10, 2025 | 1 | Canada |
The overall response assessment considers the response of the target and non-target lesions and development of new lesions. Response Classification of Target Lesions, CNS lesions and Non-Target Lesions * Complete response (CR): * Partial response (PR): * Progressive disease (PD): * Stable disease (SD):
| Arm | Type | Description |
|---|---|---|
| GCAR1 | EXPERIMENTAL | This is an intrapatient two-dose escalation study. The patient will receive two separate intravenous infusions of cryopreserved, autologous GCAR1, with at least three months (+/- 30 days) between infusions. Both infusions will be preceded by standard lymphodepleting chemotherapy (Fludarabine 40 mg/m2 x 3 days, cyclophosphamide 600 mg/m2 x 2 days) . Dose 1 will be 5.0E6 CAR+ T cells/kg patient body weight, Dose 2 will be 2.5E7 CAR+ T cells/kg patient body weight. Infusions will be intravenous, single infusions. |
| Name | Type | Description |
|---|---|---|
| GCAR1 | BIOLOGICAL | GCAR1 is a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector encoding a chimeric antigen receptor (CAR) targeting GPNMB. The CAR comprises a single-chain variable fragment (scFv) binding domain derived from a fully human GPNMB-specific monoclonal antibody (CDX-011), a CD8 hinge and transmembrane domain, and the CD137 (4-1BB) and CD3 zeta chain intracellular signaling domains. Following infusion, the autologous GPNMB CAR T-cells expressing the genetically engineered anti-GPNMB CAR enable the specific targeting of GPNMB-expressing cells. Upon binding to GPNMB-expressing cells, the CAR transmits T cell activation signals that promote the elimination of target cells through CAR T cell degranulation and the release of cytotoxic molecules. The cellular signal also facilitates CAR T cell proliferation and persistence that may enable prolonged disease control through immunosurveillance3. |
Inclusion Criteria: * The patient must provide informed consent * Adequate organ function, defined as creatinine clearance \>30 ml/min and LVEF \>45% Exclusion Criteria: * Any active uncontrolled infection * Pregnancy or nursing * Anti-cancer therapy within 21 calendar days prior to the first dos...