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CAR T-cell Therapy

Cell Therapy for Mesothelioma

Phase 1 & 2

Waitlist Available

Research Sponsored by TCR2 Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has a left ventricular ejection fraction > 45% as measured by resting echocardiogram, with no clinically significant pericardial effusion.

Patient has an Eastern Cooperative Oncology Group performance status 0 or 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up orr at 3 months; dcr based on orr + sd lasting at least 8 weeks

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to the infusion of gavo-cel, such as fever or chills; effects from modifying T cells might occur; plus typical risks associated with immuno-oncology agents like skin rash, diarrhea, liver inflammation, hormone gland problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

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I have been diagnosed with MPM, ovarian cancer, cholangiocarcinoma, or NSCLC.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ orr at 3 months; dcr based on orr + sd lasting at least 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~orr at 3 months; dcr based on orr + sd lasting at least 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and orr at 3 months; dcr based on orr + sd lasting at least 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1- Primary Objective

Phase 2- Primary Objective

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

fludarabine

2012

Completed Phase 3

~6760

Nivolumab

FDA approved