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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 by Adaptimmune Therapeutics for advanced mesothelin-expressing cancers, including mesothelioma. It is in Phase 1/2 clinical development and has not been approved by the FDA. Gavo-cel is studied in a single active trial that is no longer recruiting new participants.
Gavo-cel is being studied for the treatment of advanced mesothelioma, including pleural and peritoneal forms, in adults. The Phase 1/2 trial also enrolls patients with other mesothelin-expressing cancers such as cholangiocarcinoma, ovarian cancer, and non-small cell lung cancer. Gavo-cel remains investigational for mesothelioma.
Gavo-cel targets mesothelin, a protein expressed on the surface of mesothelioma and several other solid tumors. It is a cell therapy, reflected in the -cel suffix in its name, designed to direct a patient's own engineered T cells against mesothelin-expressing cancer cells. The trial enrolls patients whose tumors express mesothelin.
Gavo-cel is being developed by Adaptimmune Therapeutics PLC, which trades under the ticker ADAPY. The company is running the Phase 1/2 clinical program for gavo-cel in advanced mesothelin-expressing cancers, with trial sites in the United States and Canada.
Gavo-cel is in Phase 1/2 clinical development. It is investigational and has not been approved by the FDA for any indication. Its single trial, NCT03907852, is active but no longer recruiting, and has enrolled 57 participants across the United States and Canada.
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 trial is active but not recruiting, is controlled and randomized, enrolls adults 18 and older of any sex, and includes 57 participants.
Yes, gavo-cel is also known as TC-210. The Phase 1/2 trial NCT03907852 refers to the therapy as gavo-cel (TC-210), so the two names describe the same investigational mesothelin-targeted cell therapy from Adaptimmune Therapeutics.