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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...
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Gavo-cel is an investigational cell therapy being developed for mesothelioma, a cancer that affects the lining of the lungs, abdomen, and other organs. It is in Phase 1 clinical development and has not been approved by the FDA. Gavo-cel is being studied in patients with advanced mesothelin-expressing cancer.
Gavo-cel is being studied as a treatment for mesothelioma, including pleural and peritoneal forms, in patients whose tumors express mesothelin. It is investigational and has not been approved for any indication. The Phase 1/2 trial also enrolls patients with cholangiocarcinoma, ovarian cancer, and non-small cell lung cancer.
Gavo-cel targets mesothelin, a protein expressed on the surface of mesothelioma cells and several other solid tumors. It is a cell therapy, meaning the therapeutic activity comes from engineered cells rather than a conventional small molecule or antibody. Targeting mesothelin allows the therapy to recognize and act on mesothelin-expressing cancer cells.
Gavo-cel is being developed by Adaptimmune Therapeutics PLC, which trades on the Nasdaq under the ticker ADAP. The company is running the clinical program for the therapy in advanced mesothelin-expressing cancers, including mesothelioma.
Gavo-cel is in Phase 1 clinical development. It is investigational and has not received FDA approval. The ongoing study is a Phase 1/2 trial, and no completed trials of gavo-cel have been reported.
Gavo-cel is being evaluated in the Phase 1/2 trial NCT03907852, titled a trial of gavo-cel (TC-210) in patients with advanced mesothelin-expressing cancer. The study is active but not recruiting, has enrolled 57 patients, and is being conducted in the United States and Canada in adults aged 18 and older.
Yes, gavo-cel is also known as TC-210. Both names refer to the same investigational mesothelin-targeted cell therapy developed by Adaptimmune Therapeutics. The Phase 1/2 trial NCT03907852 lists the therapy under both designations, so searches for either name point to the same asset.