RecruitingPhase 1Phase 2NCT07473167

Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients

A Multi-center, Single Arm, Open-label Phase 1/2 Clinical Trial to Evaluate Safety, and to Explore Efficacy of TC011(CD19 Targeted CAR-T) in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients


Sponsor

TICAROS Co., Ltd.

Enrollment

98 participants

Start Date

Aug 3, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, phase I/II study to determine the safety and efficacy of TC011(CD19 Targeted CAR-T) in adult patients with relapsed or refractory large B-cell non -hodgkin lymphoma.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new CAR T cell therapy called TC011 — a treatment where a patient's own immune cells are genetically modified in the lab to target and destroy cancer cells — in people with large B-cell lymphoma that has come back or stopped responding to treatment. **You may be eligible if...** - You are 19 years or older - You have been diagnosed with large B-cell lymphoma that has returned or not responded to at least 2 prior treatments - You are in reasonably good health and have a life expectancy of at least 12 weeks - You have at least one measurable tumor - Your heart and organ function are adequate - You are able to undergo the cell collection process (leukapheresis) **You may NOT be eligible if...** - You have had prior CAR T cell therapy, gene therapy, or bone marrow transplant from a donor - You have active HIV, hepatitis B or C, or syphilis - You have cancer that has spread to the brain or spinal fluid - You have had major surgery in the past 4 weeks - You are pregnant or breastfeeding - Your disease is rapidly worsening Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTC011

Anti-CD19 Chimeric Antigen Receptor T cell


Locations(1)

Seoul National University Hospital

Seoul, Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07473167


Related Trials