Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

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 evaluate the efficacy of gavo-cel, with and without immuno-oncology agents, in patients with advanced mesothelin-expressing cancers, with overall response rate and disease control rate as the primary Phase 2 endpoints.

Official Title

A Phase 1/2 Single Arm Open-Label Clinical Trial of Gavocabtagene Autoleucel (Gavo-cel) in Patients With Advanced Mesothelin-Expressing Cancer

Keywords

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, High Grade Ovarian Serous Adenocarcinoma, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Cystadenocarcinoma, Serous, Cyclophosphamide, Nivolumab, Fludarabine, Ipilimumab, gavo-cel, Lymphodepletion followed by gavo-cel, Lymphodepletion followed by gavo-cel plus nivolumab, Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab

Eligibility

For people ages 18 years and up

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) at screening.
  • Patient's tumor has been pathologically reviewed by the central laboratory. For MPM and Serous Ovarian Adenocarcinoma indications, patients must have confirmed positive MSLN expression on >/= 50% of tumor cells that are 2+ and/or 3+ by immunohistochemistry. Cholangiocarcinoma and NSCLC patients must have a MSLN expression on >/= 50% of tumor cells that are 1+, 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 the exception of Cholangiocarcinoma patients who may have elected not to pursue standard frontline therapy. Regardless of tumor type, patients must not exceed 5 prior lines of therapy (excluding bridging therapy and surgical procedures). 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

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • University of Texas MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TCR2 Therapeutics
ID
NCT03907852
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 175 study participants
Last Updated