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RECRUITINGPHASE1/PHASE2

Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma

Study on the Efficacy and Safety of Autocrine p40 Chimeric Antigen Receptor T Cells Targeting CD19 and CD20 (CD19CD20-CAR.p40-T) in Refractory B-Cell Lymphoma

NCT07097207•Shenzhen University General Hospital

View on ClinicalTrials.gov

Summary

1. Study Title: A Study on the Efficacy and Safety of Autocrine p40 CD19/CD20 Dual-Targeting Chimeric Antigen Receptor T-Cells (CD19/CD20-CAR.p40-T) in Relapsed/Refractory B-Cell Lymphoma 2. Study Objectives: * Primary Objective: To evaluate the safety of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed/refractory B-cell lymphoma. * Secondary Objective: To evaluate the efficacy of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed/refractory B-cell lymphoma. 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.p40-T cell infusion or CD19 CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.

Detailed Description

A prospective, interventional Phase I/IIa clinical study to evaluate the safety and efficacy of autocrine p40 CAR-T cells targeting dual CD19/CD20 in refractory/relapsed B-cell lymphoma. A total of 20 patients aged 18 to 75 years with pathologically confirmed B-cell lymphoma (refractory/relapsed) will be enrolled. The total dose of CAR-T cells is 0.5-2×10\^6 CAR-T cells/kg, administered as a single intravenous infusion. Eligible subjects (n=20) will be assigned by the investigator to receive either CD19CD20 CAR.p40-T injection or CD19 CAR.p40-T injection. * Primary Endpoint\*\*: To assess treatment-emergent adverse events (TEAEs) within 30 days after intravenous infusion of CAR-T cells. * Secondary Endpoints\*\*: * Objective response rate (ORR=CR+PR) within 8 weeks; * Overall survival (OS) and progression-free survival (PFS) at 6 months; * In vivo expansion and persistence kinetics of CAR-T cells.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged between 15 and 75 years old, regardless of gender;
•2. Diagnosed with relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria;
•3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
•4. Expected survival time of ≥ 3 months;
•5. Confirmation of CD20 expression in tumor cells by flow cytometry/immunohistochemistry;
•6. Patients tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;
•7. No severe heart, lung, liver, or kidney diseases;
•8. Capable of understanding and willing to sign the informed consent form for this trial;
•9. No contraindications to peripheral blood apheresis for the subject;
•10. Having clearly measurable and evaluable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard;
+2 more criteria

Exclusion Criteria

•1. History of allergy to any component in the cell product;
•2. The following conditions in the blood routine examination: White blood cell count (WBC) ≤ 1×10⁹/L, absolute neutrophil count (ANC) ≤ 0.5×10⁹/L, absolute lymphocyte count (ALC) ≤ 0.5×10⁹/L, platelet count (PLT) ≤ 25×10⁹/L;
•3. The following conditions in laboratory tests: including but not limited to, total serum bilirubin ≥ 1.5 mg/dl; serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the upper limit of normal; serum creatinine ≥ 2.0 mg/dl;
•4. Patients with heart failure classified as grade III or IV according to the New York Heart Association (NYHA) classification criteria; or left ventricular ejection fraction (LVEF) \< 50% as detected by echocardiography;
•5. Abnormal lung function with oxygen saturation \< 92% under room air;
•6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically severe heart diseases within 12 months before enrollment;
•7. Grade 3 hypertension with poorly controlled blood pressure despite drug treatment;
•8. History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia or intracerebral hemorrhagic diseases;
•9. Patients with autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive agent treatment;
•10. Presence of uncontrolled active infection;
+7 more criteria

Locations (1)

Shenzhen University General Hospital

Shenzhen, Other (Non U.s.), China

Key Dates

Start Date

October 1, 2023

Primary Completion Date

September 30, 2026

Completion Date

September 30, 2026

Last Updated

July 31, 2025

Enrollment

ESTIMATED participants

Conditions

Relapsed/Refractory B-cell Lymphoma

Interventions

CAR-T cell

COMBINATION_PRODUCT

Contacts

lixin wang

CONTACT

0755-21839999 wanglixin1991@sohu.com

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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: July 31, 2025Data 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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Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma

Inclusion Criteria

Exclusion Criteria

Study Evaluating ISM8207 in Participants With Advanced Solid Tumors and Relapsed/Refractory B-Cell Lymphoma

Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T

A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Childhood R/R ALL and Lymphoma Subjects