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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03907852 | Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 57 | — | — | Apr 15, 2019 | Nov 2, 2028 | Aug 27, 2025 | 11 | United States, Canada |
Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.
To evaluate the efficacy of autologous genetically modified T cells (gavo-cel), with or without immuno-oncology agents, in patients with MSLN-expressing unresectable, metastatic, or recurrent cancers as determined by overall response rate and disease control rate using RECIST v1.1 (or mesothelioma-specific RECIST criteria, if applicable).
| Arm | Type | Description |
|---|---|---|
| Lymphodepletion followed by gavo-cel | EXPERIMENTAL | fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel |
| Lymphodepletion followed by gavo-cel plus nivolumab | EXPERIMENTAL | fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel |
| Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab | EXPERIMENTAL | fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel and ipilimumab 1mg/kg every 6 weeks starting on Day 42 post gavo-cel |
| Name | Type | Description |
|---|---|---|
| gavo-cel | BIOLOGICAL | gavo-cel |
| fludarabine | DRUG | lymphodepletion chemotherapy |
| cyclophosphamide | DRUG | lymphodepletion chemotherapy |
| Nivolumab | DRUG | immuno-oncology agent |
| Ipilimumab | DRUG | immuno-oncology agent |
Inclusion Criteria: * Patient is at least 18 years of age at the time the Informed Consent is signed. * Patient has a pathologically confirmed diagnosis of either Malignant Pleural/Peritoneal Mesothelioma (MPM), Serous Ovarian Adenocarcinoma, Cholangiocarcinoma, or Non-Small Cell Lung Cancer (NSCLC...