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Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer

NCT03907852 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-08-27

No results posted yet for this study

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.

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
  • High Grade Ovarian Serous Adenocarcinoma

Interventions

BIOLOGICAL

gavo-cel

gavo-cel

DRUG

fludarabine

lymphodepletion chemotherapy

DRUG

cyclophosphamide

lymphodepletion chemotherapy

DRUG

Nivolumab

immuno-oncology agent

DRUG

Ipilimumab

immuno-oncology agent

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2024-11-19
Completion
2028-11-02
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03907852 on ClinicalTrials.gov