RecruitingPhase 1Phase 2NCT04836507

Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia 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 and B-cell Acute Lymphoblastic Leukemia


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 and B-cell Acute Lymphoblastic Leukemia.


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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALCRC01

Cohort A :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. Cohort B :A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 1.5 x 10\^6 anti-CD19 CAR T cells/kg.

DRUGFludarabine

Administered according to package insert

DRUGCyclophosphamide

Administered according to package insert


Locations(2)

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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

Visit

NCT04836507


Related Trials