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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.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up orr at 3 months; dcr based on orr + sd lasting at least 8 weeks
Awards & highlights

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.

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.Check my eligibility
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.See study design
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've had at least one standard treatment for my advanced cancer before considering gavo-cel, except if I have Cholangiocarcinoma.
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I am healthy enough for a procedure to collect white blood cells and have good veins for it.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My organ functions are within the required range.
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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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1- Primary Objective
Phase 2- Primary Objective

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
Ipilimumab
FDA approved
cyclophosphamide
1994
Completed Phase 3
~8140

Find a Location

Who is running the clinical trial?

TCR2 TherapeuticsLead Sponsor
2 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Ovarian Cancer
6 Patients Enrolled for Ovarian Cancer
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,500 Total Patients Enrolled
11 Trials studying Ovarian Cancer
1,181 Patients Enrolled for Ovarian Cancer
ClinicalStudy ChairTCR2 Therapeutics
1 Previous Clinical Trials
6 Total Patients Enrolled

Media Library

Gavo-cel (TC-210) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03907852 — Phase 1 & 2
Ovarian Cancer Research Study Groups: Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab, Lymphodepletion followed by gavo-cel plus nivolumab, Lymphodepletion followed by gavo-cel
Ovarian Cancer Clinical Trial 2023: Gavo-cel (TC-210) Highlights & Side Effects. Trial Name: NCT03907852 — Phase 1 & 2
Gavo-cel (TC-210) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03907852 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedent studies which investigated the efficacy of gavo-cel?

"At present, 889 live studies are conducting research into gavo-cel with 161 of these in Phase 3. Philadelphia, Pennsylvania is one hub for this research; however there exist 28443 locations running trials on the drug."

Answered by AI

What medical ailments does gavo-cel have proven efficacy for?

"Gavo-cel has been known to be an effective treatment option for a variety of conditions, including multiple sclerosis, mixed-cell type lymphoma, and acute myelocytic leukemia."

Answered by AI

Is there an open enrollment period for this exploration?

"According to clinicaltrials.gov, this trial remains open and accepting participants; the study was first advertised on April 15th 2019 with the most recent update posted on May 24th 2022."

Answered by AI

How many participants has this research study accrued?

"The trial sponsors, TCR2 Therapeutics, must recruit 175 eligible patients for the medical experiment. The primary sites of operation are National Cancer Institute in Bethesda and Sarah Cannon Research Institute in Nashville."

Answered by AI

Are there various sites actively conducting this experiment within the state?

"This trial is scattered across the world, featuring 7 locations such as National Cancer Institute in Bethesda, Sarah Cannon Research Institute in Nashville and Princess Margaret Cancer Centre in Toronto."

Answered by AI
~17 spots leftby Nov 2028