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

Last updated: January 28, 2026
Sponsor: Peking University
Overall Status: Completed

Phase

1

Condition

Lymphoma

Lymphoma, B-cell

Treatment

CD19/CD20-directed Chimeric Antigen Receptor T Cells

Clinical Study ID

NCT05149391
0702-022
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 histologyaccording to World Health Organization 2016 criteria;

  6. Patients with a clear diagnosis of relapsed and/or refractory B-Non-Hodgkin'slymphoma, including Diffuse Large B Cell Lymphoma, Follicular Lymphoma and MantleCell Lymphoma. Diffuse Large B Cell Lymphoma includes the following types:

  7. Diffuse Large B Cell Lymphoma, Non Specifically

  8. Primary Mediastinal B-cell Lymphoma

  9. Transformed Follicular Lymphoma

  10. High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6

  11. High Grade B-Cell Lymphoma, Non Specifically

  12. For CD20-positive subjects, they should have received at least one regimencontaining anti-CD20-targeted therapy (such as rituximab). If they do not completethe regimen due to intolerance, the cause of intolerance should be recorded;

  13. No contraindications of apheresis.

  14. At least one measurable lesion according to Lugano 2014 criteria;

  15. Adequate organ function and adequate bone marrow reserve

  16. Hemoglobin≥80 g/L

  17. Absolute neutrophil count≥1.0×109/L

  18. Platelet≥50×109/L,

  19. Creatinine≤1.5×upper limit of the normal range (ULN)

  20. Cardiac ejection fraction≥50%

  21. Saturation of Pulse Oxygen>92%

  22. Total bilirubin≤1.5×ULN

  23. Alanine Aminotransferase/Aspartate Aminotransferase≤3×ULN

Exclusion

Exclusion Criteria:

  1. Malignant tumors other than B-Non-Hodgkin's lymphoma within 5 years prior toscreening, except cervical carcinoma in situ, basal cell or squamous cell skincancer, local prostate cancer after radical surgery, and breast ductal carcinoma insitu after radical surgery;

  2. Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus or treponemapallidum infection ;

  3. Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease needtreatment;

  4. Female subjects who have been pregnant or breastfeeding, or who plan to conceiveduring or within 1 year after treatment, or male subjects' partner plans to conceivewithin 1 year after their cell transfusion;

  5. Active or uncontrolled infections requiring systemic treatment within 14 days beforeenrollment;

  6. Patients who have been previously infected with tuberculosis;

  7. Administered Corticosteroids and/or other immunosuppressants within 7 days beforeapheresis. and 5 days before the infusion of C-CAR039;

  8. Patients with central nervous system involvement;

Study Design

Total Participants: 3
Treatment Group(s): 1
Primary Treatment: CD19/CD20-directed Chimeric Antigen Receptor T Cells
Phase: 1
Study Start date:
July 20, 2021
Estimated Completion Date:
May 30, 2024

Study 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.

Connect with a study center

  • Peking University Cancer Hospital

    Beijing,
    China

    Site Not Available

  • Peking University Cancer Hospital

    Beijing 1816670,
    China

    Site Not Available

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