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

NCT04836507 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2026-07-01

No results posted yet for this study

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.

Conditions

  • Relapsed Large B-cell Lymphoma
  • Refractory Large B-cell Lymphoma
  • Diffuse Large B-cell Lymphoma (DLBCL)
  • Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
  • High-grade B-cell Lymphoma
  • Transformed Follicular Lymphoma (TFL)
  • ALL (Acute B-Lymphoblastic Leukemia)

Interventions

BIOLOGICAL

CRC01

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.

DRUG

Fludarabine

Administered according to package insert

DRUG

Cyclophosphamide

Administered according to package insert

Sponsors & Collaborators

  • Curocell Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2030-08-15
Completion
2030-09-26

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04836507 on ClinicalTrials.gov