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A Study of C-CAR039 in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of C-CAR039 in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma

A Phase 1 Study of CD19 and CD20 Targeted Chimeric Antigen Receptor T Cells Therapy (C-CAR039) in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma

NCT05149391•Peking University

View on ClinicalTrials.gov

Summary

This is a single-center, open-label study to evaluate the safety and efficacy of C-CAR039 in relapsed and/or refractory B cell Non-Hodgkin's Lymphoma patients.

Detailed Description

The study includes the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Baseline testing, Lymphodepletion, C-CAR039 infusion, Dose-limiting toxicity observation and Follow-up Visit.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient volunteered to participate in the study and signed the Informed Consent;
•2. Age, 18-70 years (include 18 and 70), male or female;
•3. Expected survival ≥ 12 weeks
•4. Eastern Cooperative Oncology Group score 0-2
•5. CD19 or CD20 positive B-Non-Hodgkin's lymphoma confirmed by cytology or histology according to World Health Organization 2016 criteria;
•6. Patients with a clear diagnosis of relapsed and/or refractory B-Non-Hodgkin's lymphoma, including Diffuse Large B Cell Lymphoma, Follicular Lymphoma and Mantle Cell Lymphoma. Diffuse Large B Cell Lymphoma includes the following types:
•1. Diffuse Large B Cell Lymphoma, Non Specifically
•2. Primary Mediastinal B-cell Lymphoma
•3. Transformed Follicular Lymphoma
•4. High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6
+13 more criteria

Exclusion Criteria

•1. Malignant tumors other than B-Non-Hodgkin's lymphoma within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;
•2. Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus or treponema pallidum infection ;
•3. Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need treatment;
•4. Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion;
•5. Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
•6. Patients who have been previously infected with tuberculosis;
•7. Administered Corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of C-CAR039;
•8. Patients with central nervous system involvement;

Locations (1)

Peking University Cancer Hospital

Beijing, China

Key Dates

Start Date

July 20, 2021

Primary Completion Date

January 30, 2024

Completion Date

May 30, 2024

Last Updated

January 30, 2026

Enrollment

ACTUAL participants

Conditions

B Cell Non-Hodgkin's Lymphoma

Interventions

CD19/CD20-directed Chimeric Antigen Receptor T Cells

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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