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
Brief Summary
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Phase 1 - Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.
Condition
Mesothelioma
Intervention
gavo-cel
Study Arms / Comparison Groups
gavo-cel
Description: gavo-cel
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
70
Start Date
April 15, 2019
Completion Date
January 2023
Primary Completion Date
June 2021
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Clinical, 617-949-5668, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03907852
Organization ID
TCR2-18-01
Responsible Party
Sponsor
Study Sponsor
TCR2 Therapeutics
Study Sponsor
Clinical, Study Chair, TCR2 Therapeutics
Verification Date
December 2020