Cell Therapy for Mesothelioma

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: TCR2 Therapeutics

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with certain advanced cancers (like mesothelioma, ovarian cancer, bile duct cancer, or lung cancer) that express a protein called Mesothelin can join this trial if they've already tried at least one standard treatment (except for bile duct cancer patients who may not have). They need to be fairly healthy and active, with good heart function and no serious fluid around the heart.

Inclusion Criteria

I've had at least one standard treatment for my advanced cancer before considering gavo-cel, except if I have Cholangiocarcinoma.

I am healthy enough for a procedure to collect white blood cells and have good veins for it.

My heart pumps well and I don't have serious fluid around it.

+5 more

Participant Groups

The study is testing gavo-cel (TC-210), a new type of T cell therapy designed to target Mesothelin on cancer cells. It's given alone or with immune-boosting drugs like Nivolumab and Ipilimumab. The goal is to find the best dose and see how well it works against these cancers.

3Treatment groups

Experimental Treatment

Group I: Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumabExperimental Treatment5 Interventions

fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel and ipilimumab 1mg/kg every 6 weeks starting on Day 42 post gavo-cel

Group II: Lymphodepletion followed by gavo-cel plus nivolumabExperimental Treatment4 Interventions

fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel

Group III: Lymphodepletion followed by gavo-celExperimental Treatment3 Interventions

fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel