Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
gavo-cel · 1 trial · 11 indications
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...
Gavo-cel is an investigational cell therapy being studied for the treatment of mesothelioma, a type of cancer that affects the lining of the lungs and other organs. It is also being evaluated in other mesothelin-expressing cancers, including ovarian cancer, non-small cell lung cancer, and cholangiocarcinoma.
Gavo-cel targets mesothelin, a protein that is overexpressed on the surface of many solid tumors, including mesothelioma, ovarian cancer, and non-small cell lung cancer. By targeting mesothelin, gavo-cel is designed to direct the immune system to attack cancer cells that express this protein.
Gavo-cel is being developed by Adaptimmune Therapeutics PLC, a biopharmaceutical company focused on developing T-cell therapies for cancer. The company's sponsored ADR trades under the ticker symbol ADAP on the NASDAQ stock exchange.
Gavo-cel is currently in Phase 1 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and efficacy in clinical trials.
Gavo-cel is being studied in a Phase 1/2 clinical trial with the identifier NCT03907852. This trial is evaluating gavo-cel in patients with advanced mesothelin-expressing cancers, including mesothelioma, and is currently active but not recruiting participants.
Yes, gavo-cel is also known as TC-210. The clinical trial NCT03907852, which is studying gavo-cel, is titled 'Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer,' confirming that these names refer to the same investigational cell therapy.