gavo-cel for Mesothelioma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mesothelioma+18 More
gavo-cel - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cell therapy that consists of T cells that have been genetically engineered to express a single-domain antibody that recognizes human Mesothelin. The T cells are fused to the CD3-epsilon subunit, which is incorporated into the endogenous T cell receptor (TCR) complex. The aim of the trial is to establish the recommended Phase 2 dose and to evaluate the efficacy of the therapy in patients with advanced mesothelin-expressing cancers.

Eligible Conditions
  • Mesothelioma
  • Malignant mesothelioma
  • Malignant Pleural Mesothelioma
  • Ovarian Cancer
  • Cholangiocarcinoma
  • Mesothelioma, Malignant
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Pleura Mesothelioma
  • Mesothelioma; Peritoneum
  • High Grade Ovarian Serous Adenocarcinoma
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: ORR at 3 months; DCR based on ORR + SD lasting at least 8 weeks

Day 28
Phase 1 - Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.
Phase 1- Primary Objective
Month 3
Phase 2- Primary Objective
Month 3
Phase 2 - To evaluate the efficacy of autologous genetically modified T cells (gavo-cel) in patients with MSLN-expressing unresectable, metastatic, or recurrent cancers as determined by overall response rate using RECIST v1.1

Trial Safety

Safety Progress

1 of 3

Trial Design

5 Treatment Groups

Lymphodepletion followed by gavo-cel plus nivolumab
1 of 5
Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab
1 of 5
gavo-cel
1 of 5
Phase 2 Dose
1 of 5
Lymphodepletion followed by gavo-cel
1 of 5
Experimental Treatment

175 Total Participants · 5 Treatment Groups

Primary Treatment: gavo-cel · No Placebo Group · Phase 1 & 2

Lymphodepletion followed by gavo-cel plus nivolumabExperimental Group · 4 Interventions: fludarabine, gavo-cel, Nivolumab, cyclophosphamide · Intervention Types: Drug, Biological, Drug, Drug
Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumabExperimental Group · 5 Interventions: fludarabine, gavo-cel, Nivolumab, Ipilimumab, cyclophosphamide · Intervention Types: Drug, Biological, Drug, Drug, Drug
gavo-cel
Biological
Experimental Group · 1 Intervention: gavo-cel · Intervention Types: Biological
Phase 2 DoseExperimental Group · 4 Interventions: fludarabine, anti-PD1, gavo-cel, cyclophosphamide · Intervention Types: Drug, Biological, Biological, Drug
Lymphodepletion followed by gavo-celExperimental Group · 3 Interventions: fludarabine, gavo-cel, cyclophosphamide · Intervention Types: Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Nivolumab
2014
Completed Phase 3
~5340
Ipilimumab
2014
Completed Phase 3
~3390
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: orr at 3 months; dcr based on orr + sd lasting at least 8 weeks

Who is running the clinical trial?

TCR2 TherapeuticsLead Sponsor
2 Previous Clinical Trials
235 Total Patients Enrolled
1 Trials studying Mesothelioma
115 Patients Enrolled for Mesothelioma
Bristol-Myers SquibbIndustry Sponsor
2,481 Previous Clinical Trials
3,919,417 Total Patients Enrolled
14 Trials studying Mesothelioma
1,922 Patients Enrolled for Mesothelioma
ClinicalStudy ChairTCR2 Therapeutics
1 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a minimum age of 18 years.
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.
Patient has an Eastern Cooperative Oncology Group performance status of 0 or 1.
You are fit for leukapheresis and have adequate venous access for the cell collection.
You have an adequate organ function as indicated by the laboratory values in the clinical protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: October 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.