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Recruiting Phase 1/2

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

NCT07508605 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2025-01-01
Last updated
2026-04-02

Condition(s) studied

Relapsed/Refractory B-cell Lymphoma

Investigational drug(s) / intervention(s)

CAR/TRuC-T

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • TEAEs — From date of initial treatment to the 30 days after treatment
    Adverse events during treatment

Trial sites (1)

FacilityCityRegionStatus
Shenzhen University General Hospital Shenzhen Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07508605 on ClinicalTrials.gov ↗ ← All trials in China