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

NCT07097207 | Recruiting Phase 1

• 1 other identifier: 111
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.
• 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.

Conditions

Relapsed/Refractory B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• TEAEs

  Adverse events during treatment

  From date of initial treatment to the 30 days after treatment

Secondary Outcomes (1)

• Disease-related clinical responses

  From date of enrollment until the date of clinical responses,up to 2 years

Study Arms (1)

CART group

EXPERIMENTAL

Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20-CAR.p40-T or CD19-CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.

Combination Product: CAR-T cell

Interventions

CAR-T cell COMBINATION_PRODUCT

Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20-CAR.p40-T or CD19-CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.

CART group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 15 and 75 years old, regardless of gender;
• Diagnosed with relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• Expected survival time of ≥ 3 months;
• Confirmation of CD20 expression in tumor cells by flow cytometry/immunohistochemistry;
• Patients tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;
• No severe heart, lung, liver, or kidney diseases;
• Capable of understanding and willing to sign the informed consent form for this trial;
• No contraindications to peripheral blood apheresis for the subject;
• Having clearly measurable and evaluable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard;
• The subject must have received standard first- and second-line treatment regimens;
• Not having received antibody-based drug treatment within 2 weeks before cell therapy.

You may not qualify if:

• History of allergy to any component in the cell product;
• 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;
• 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;
• 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;
• Abnormal lung function with oxygen saturation \< 92% under room air;
• Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically severe heart diseases within 12 months before enrollment;
• Grade 3 hypertension with poorly controlled blood pressure despite drug treatment;
• History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia or intracerebral hemorrhagic diseases;
• Patients with autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive agent treatment;
• Presence of uncontrolled active infection;
• Previous use of any CAR-T cell product or other genetically modified T cell therapies;
• Vaccination with live vaccines within 4 weeks before enrollment;
• Subjects positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Treponema pallidum particle agglutination assay (TPPA)/rapid plasma reagin (RPR), as well as HBV carriers;
• History of alcohol abuse, drug abuse, or mental illness in the subject;
• The subject participated in any other clinical study within 3 months before joining this clinical study;

Sponsors & Collaborators

• Shenzhen University General Hospital: lead

Study Sites (1)

Shenzhen University General Hospital

Shenzhen, Other (Non U.s.), 518055, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Lixin Wang, PHD

  Shenzhen University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lixin wang

CONTACT

0755-21839999; wanglixin1991@sohu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 31, 2025
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)