Description:
Gavocabtagene autoleucel (gavo-cel; TC-210) is a novel cell therapy that consists of
autologous genetically engineered T cells expressing a single-domain antibody that recognizes
human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated
into the endogenous T cell receptor (TCR) complex.
This Phase 1/2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently
determine an overall response rate in patients with advanced mesothelin-expressing cancers.
Title
- Brief Title: Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer
- Official Title: A Phase 1/2 Single Arm Open-Label Clinical Trial of Gavocabtagene Autoleucel (Gavo-cel) in Patients With Advanced Mesothelin-Expressing Cancer
Clinical Trial IDs
- ORG STUDY ID:
TCR2-18-01
- NCT ID:
NCT03907852
Conditions
- Mesothelioma
- Mesothelioma, Malignant
- Mesothelioma; Pleura
- Mesotheliomas Pleural
- Mesothelioma Peritoneum
- Cholangiocarcinoma
- Cholangiocarcinoma Recurrent
- Ovarian Cancer
- Non Small Cell Lung Cancer
- Non Small Cell Lung Cancer Metastatic
Interventions
Drug | Synonyms | Arms |
---|
gavo-cel | | Lymphodepletion followed by gavo-cel |
fludarabine | | Lymphodepletion followed by gavo-cel |
cyclophosphamide | | Lymphodepletion followed by gavo-cel |
anti-PD1 | | Phase 2 Dose |
Purpose
Gavocabtagene autoleucel (gavo-cel; TC-210) is a novel cell therapy that consists of
autologous genetically engineered T cells expressing a single-domain antibody that recognizes
human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated
into the endogenous T cell receptor (TCR) complex.
This Phase 1/2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently
determine an overall response rate in patients with advanced mesothelin-expressing cancers.
Trial Arms
Name | Type | Description | Interventions |
---|
gavo-cel | Experimental | gavo-cel | |
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 TC-210 T Cells | - gavo-cel
- fludarabine
- cyclophosphamide
|
Phase 2 Dose | Experimental | MPM, cholangiocarcinoma, and ovarian cancer will receive gavo-cel at the RP2D; NSCLC patients will receive gavo-cel at the RP2D or gavo-cel at the RP2D followed by anti-PD1 | - gavo-cel
- fludarabine
- cyclophosphamide
- anti-PD1
|
Eligibility Criteria
Inclusion Criteria:
- Patient is > 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).
- Patient's tumor has been pathologically reviewed by the central laboratory with
confirmed positive MSLN expression on > 50% of tumor cells that are 2+ and/or 3+ by
immunohistochemistry.
- Prior to gavo-cel infusion, patients must have received at least 1 systemic standard
of care therapy for metastatic or unresectable disease with more details provided in
the clinical protocol
- Patient has an Eastern Cooperative Oncology Group performance status 0 or 1.
- Patient has a left ventricular ejection fraction > 45% as measured by resting
echocardiogram, with no clinically significant pericardial effusion.
- Patient is fit for leukapheresis and has adequate venous access for the cell
collection.
- Patient must have adequate organ function as indicated by the laboratory values in the
clinical protocol
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Phase 1 - Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events. |
Time Frame: | DLTs within 28 days post-treatment |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | TCR2 Therapeutics |
Last Updated
June 29, 2021