RecruitingPhase 1Phase 2NCT04836507

Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma Patients

An Open-label, Multi-center, Single-arm Phase 1/2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Adult Patients With Relapsed or Refractory Large B-cell Lymphoma


Sponsor

Curocell Inc.

Enrollment

91 participants

Start Date

Mar 2, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, phase I/II study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called CRC01 — a treatment that uses a patient's own immune cells, re-engineered in a lab to attack cancer — in adults with large B-cell lymphoma that has come back or stopped responding to previous treatments. **You may be eligible if:** - You are 19 years of age or older - You have been diagnosed with a large B-cell lymphoma (such as diffuse large B-cell lymphoma or high-grade B-cell lymphoma) - Your lymphoma has returned or stopped responding after at least two rounds of chemotherapy - You are either not eligible for, or have already tried and failed, a stem cell transplant - You are in reasonably good health (ECOG 0–1) with adequate kidney, liver, and blood cell counts **You may NOT be eligible if:** - Your lymphoma has spread to the brain or spinal fluid - You have active hepatitis B, hepatitis C, or HIV - You have previously received CAR-T or other gene therapy treatments - 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.

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Interventions

BIOLOGICALCRC01

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.

DRUGFludarabine

Administered according to package insert

DRUGCyclophosphamide

Administered according to package insert


Locations(1)

Samsung Medical Center

Seoul, South Korea

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NCT04836507


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