Efficacy and Safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma (CAR/TRuC-T)

March 27, 2026 updated by: Shenzhen University General Hospital

  1. Study Title:

    A Study on the Efficacy and safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma

  2. Study Objectives:

    Primary Objective: To evaluate the safety of CD19/CD20 CAR/TRuC-T cell therapy in patients with relapsed/refractory B-cell lymphoma.

    Secondary Objective: To evaluate the efficacy of CD19/CD20 CAR/TRuC-T cell therapy in patients with relapsed/refractory B-cell lymphoma.

    Exploratory Objective: To assess in vivo expansion and persistence of infused CD19/CD20 CAR/TRuC-T cells.

  3. Participant Intervention:

Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20 CAR/TRuC-T cell infusion. The CAR/TRuC-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Detailed Description:

This is a prospective, interventional Phase I/II clinical study designed to evaluate the safety and efficacy of CD19/CD20 CAR/TRuC-T cell therapy in patients with relapsed/refractory B-cell lymphoma. A total of 20 patients aged 18-75 years with relapsed/refractory B-cell lymphoma will be enrolled. All patients must have histopathologically confirmed disease and positive CD20 expression in tumor tissue.

CD19/CD20 CAR/TRuC-T cells will be administered as a single intravenous infusion at a total dose of 0.5-2 × 10^6 CAR-T cells/kg. Eligible subjects (N=20) will be assigned by the investigator to receive CD19/CD20 CAR/TRuC-T cell infusion.

Endpoints:

  • Primary Endpoint:

    o Incidence and severity of treatment-emergent adverse events (TEAEs) within 30 days after CD19/CD20 CAR/TRuC-T cell infusion.

  • Secondary Endpoints:

    • Objective response rate (ORR = CR + PR) assessed within 8 weeks after infusion;
    • Overall survival (OS) and progression-free survival (PFS) at 6 months;
    • In vivo expansion and persistence kinetics of infused CD19/CD20 CAR/TRuC-T cells.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518055
        • Recruiting
        • Shenzhen university General Hospital
        • Contact:
        • Principal Investigator:
          • LI YU, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Subjects must meet all of the following criteria to be enrolled:

  1. Aged 18 to 75 years, regardless of sex;
  2. Histologically confirmed relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) classification;
  3. ECOG performance status of 0-2;
  4. Expected survival of at least 3 months;
  5. CD20 expression on tumor cells confirmed by flow cytometry and/or immunohistochemistry;
  6. Patients who are resistant/refractory to CD19 CAR-T cell therapy or have low CD19 expression;
  7. No severe cardiac, pulmonary, hepatic, or renal disease;
  8. Able to understand and willing to sign the informed consent form for this study;
  9. No contraindications to peripheral blood mononuclear cell collection/apheresis;
  10. At least one measurable and evaluable lesion according to RECIST 1.1;
  11. Must have previously received standard first-line and second-line therapy;
  12. No antibody-based therapy within 2 weeks prior to cell therapy. Exclusion Criteria

Subjects meeting any of the following criteria will be excluded:

  1. History of allergy to any component of the cell product;
  2. Abnormal complete blood count meeting any of the following: WBC ≤1 × 10⁹/L, ANC ≤0.5 × 10⁹/L, ALC ≤0.5 × 10⁹/L, or PLT ≤25 × 10⁹/L;
  3. Laboratory abnormalities including, but not limited to, any of the following: total serum bilirubin ≥1.5 mg/dL; ALT or AST >2.5 times the upper limit of normal; serum creatinine ≥2.0 mg/dL;
  4. New York Heart Association (NYHA) Class III or IV heart failure, or left ventricular ejection fraction (LVEF) <50% on echocardiography;
  5. Abnormal pulmonary function, with oxygen saturation <92% on room air;
  6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;
  7. Grade 3 hypertension with poor blood pressure control despite medication;
  8. History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease;
  9. Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy;
  10. Presence of uncontrolled active infection;
  11. Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;
  12. Receipt of a live vaccine within 4 weeks prior to enrollment;
  13. Positive for HIV, HBV, HCV, or TPPA/RPR, or HBV carrier status;
  14. History of alcohol abuse, drug abuse, or psychiatric illness;
  15. Participation in any other clinical study within 3 months prior to enrollment in this study;

  16. Female subjects meeting any of the following conditions:

    1. currently pregnant or breastfeeding;
    2. planning to become pregnant during the study period; or
    3. of childbearing potential and unwilling or unable to use effective contraception;
  17. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAR/TRuC-T
Combination product: CAR/TRuC-T
Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20 CAR/TRuC-T cell infusion. The CAR/TRuC-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TEAEs
Time Frame: From date of initial treatment to the 30 days after treatment
Adverse events during treatment
From date of initial treatment to the 30 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-related clinical responses
Time Frame: From date of enrollment until the date of clinical responses,up to 2 years
Disease-related clinical responses include CR/PR/SD/PD
From date of enrollment until the date of clinical responses,up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen University General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113 (Other Identifier: Shenzhen Universisty general hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relapsed/Refractory B-cell Lymphoma

Clinical Trials on CAR/TRuC-T

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe