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CAR T-cell Therapy

TC-510 Cell Therapy for Cancer

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 is > 18 years of age at the time the Informed Consent is signed
Patient is fit for leukapheresis and has adequate venous access for the cell collection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post-treatment
Awards & highlights

Study Summary

This trial is testing a new cell therapy for cancer that uses genetically engineered T cells. The T cells are modified to express two synthetic constructs: a single-domain antibody that recognizes human Mesothelin, and a PD-1:CD28 switch receptor. The PD-1:CD28 switch is designed to produce a costimulatory signal upon engagement with PD-L1 on cancer cells.

Who is the study for?
This trial is for adults over 18 with certain advanced cancers (like mesothelioma, ovarian, pancreatic, colorectal, or triple-negative breast cancer) that express a protein called Mesothelin. Participants should be relatively healthy (ECOG status 0 or 1), have good organ function and no more than five prior systemic therapies for their cancer. They must also be suitable for leukapheresis—a procedure to collect white blood cells.Check my eligibility
What is being tested?
The trial tests TC-510 cell therapy in patients with Mesothelin-expressing cancers. It involves modifying the patient's T cells to target cancer cells better using two synthetic constructs: one that recognizes Mesothelin and another that turns off immune suppression signals from tumors.See study design
What are the potential side effects?
Potential side effects of TC-510 may include reactions related to the infusion process, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, and possible autoimmune-like conditions due to altered immune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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I am fit for a procedure to collect white blood cells and have good vein access.
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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 have been diagnosed with a specific type of cancer such as MPM, ovarian, pancreatic, TNBC, or colorectal.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I've had 1 to 5 treatments for cancer that can't be removed by surgery.
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My tumor shows high levels of MSLN protein.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post-treatment 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 - Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.
Phase 2 - Disease Control Rate (DCR)
Phase 2 - Overall Response Rate (ORR)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lymphodepletion followed by TC-510Experimental Treatment3 Interventions
Lymphodepletion (fludarabine and cyclophosphamide) followed by TC-510 T cells
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1080
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

TCR2 TherapeuticsLead Sponsor
2 Previous Clinical Trials
42 Total Patients Enrolled
1 Trials studying Mesothelioma
36 Patients Enrolled for Mesothelioma

Media Library

TC-510 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05451849 — Phase 1 & 2
Mesothelioma Research Study Groups: Lymphodepletion followed by TC-510
Mesothelioma Clinical Trial 2023: TC-510 Highlights & Side Effects. Trial Name: NCT05451849 — Phase 1 & 2
TC-510 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05451849 — Phase 1 & 2

Frequently Asked Questions

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

How many participants are eligible to partake in the experiment?

"Affirmative. Clinicaltrials.gov reveals that this experiment has been actively recruiting volunteers since June 21st 2022, with the most recent update occuring on September 21st 2022. The trial is looking for 115 subjects at 2 distinct medical facilities."

Answered by AI

Is the enrollment process for this trial currently open?

"This clinical trial is currently enrolling participants, as indicated on its page hosted by clinicaltrials.gov. It was initially published on June 21st 2022 and has been amended most recently on September 21st 2022."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
How old are they?
18 - 65
What site did they apply to?
National Cancer Institute
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
2022. "A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05451849.
All > Intrahepatic Cholangiocarcinoma > Bowel Cancer
~4 spots leftby Oct 2028
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