An Open and Dose-escalation Early Clinical Study of CD19 and CD20 CAR-T Cell Therapy for Relapsed or Refractory Aggressive B-cell Lymphoma

NCT07344818 | Recruiting Early Phase 1

• 1 other identifier: CD19+CD20 dual CAR-T
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

To observe the efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory or relapsed aggressive B-cell lymphoma

Conditions

R/R Aggressive B-cell Lymphoma

Keywords

CD19+CD20 dual CAR-T; B-NHL; CAR-T

Outcome Measures

Primary Outcomes (1)

• the safety of CD19⁺CD20 CAR-T therapy

  To evaluate the incidence and severity of AEs and SAEs in the treatment of relapsed or refractory CD19 and/or CD20 positive aggressive B-cell lymphoma patients after infused the CD19+CD20 CAR-T cells

  1 year after CAR-T cells therapy

Study Arms (1)

CAR-T cells therapy

EXPERIMENTAL

eligible patients will be treated with CD19+CD20 dual CAR-T cells

Biological: CAR-T cell therapy

Interventions

CAR-T cell therapy BIOLOGICAL

autologous CD19+CD20 dual CAR-T cells, single injection

CAR-T cells therapy

Eligibility Criteria

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

You may qualify if:

• The subject or his/her legal guardian is able to understand and voluntarily sign the informed consent form (ICF).
• Male or female subjects aged ≥18 years at the time of signing the ICF.
• An expected life expectancy of at least 12 weeks.
• An ECOG performance status of 0-2 at the time of signing the ICF.
• A diagnosis of relapsed or refractory aggressive B-cell lymphoma at the time of signing the ICF. Subjects must have previously received treatment with anthracycline-containing chemotherapy and rituximab (or other CD20-targeted agents), and must have experienced relapse or progression after at least two prior lines of therapy or autologous hematopoietic stem cell transplantation (ASCT).
• Presence of measurable positive lesions as defined by the Lugano criteria.
• Lymphoma lesions confirmed by biopsy to screening demonstrating expression of CD19 and/or CD20.
• Adequate major organ function.
• contraception.

You may not qualify if:

• Lymphoma involving only the central nervous system (CNS) (except for secondary CNS lymphoma).
• History of CNS disorders.
• History of autoimmune disease requiring systemic immunosuppressive therapy within 4 weeks prior to signing the ICF.
• Presence of any uncontrolled active infection at the time of signing the ICF or within 2 weeks prior to leukapheresis, requiring antibiotic, antiviral, or antifungal treatment.
• Evidence of active infection, including: HBV DNA、Positive anti-HCV antibody with detectable HCV RNA、Positive HIV antibody、Positive cytomegalovirus (CMV) DNA、Positive Epstein-Barr virus (EBV) DNA、Positive both treponemal-specific and non-specific serologic tests for syphilis.
• Clinically significant cardiovascular disease.
• Known hypersensitivity to any component of the investigational products used in this study.
• Receipt of any disease-related investigational therapy or other systemic antitumor therapy prior to leukapheresis and within 5 half-lives of the drug.
• Requirement for systemic corticosteroids (at a dose equivalent to ≥20 mg/day of prednisone) or other immunosuppressive agents within 2 weeks prior to signing the ICF, within 2 weeks prior to leukapheresis, or during the study.
• Major surgery (excluding routine biopsy) within 4 weeks prior to signing the ICF, or planned major surgery during the study period.
• History of another primary malignancy within 5 years prior to signing the ICF, except for:
• Adequately treated and cured carcinoma in situ of the cervix;
• Localized basal cell carcinoma or squamous cell carcinoma of the skin.
• Receipt of a live attenuated vaccine within 4 weeks prior to signing the ICF, or planned vaccination with a live attenuated vaccine during the screening period.
• Any condition or complication that, in the investigator's opinion, may affect protocol compliance or make the subject unsuitable for participation in the study.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Hebei Senlang Biotechnology Co., LTD: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Interventions

Immunotherapy, Adoptive

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Xiaodong Mo, PhD

CONTACT

(86)010-88325531; mxd453@163.com

Meng Lv, PhD

CONTACT

(86)010-88325531; drlvmeng@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Peking University Institute of Hematology

Model Details: A 3+3 dose-escalation design will be conducted across different dose levels (2E6/kg, 4E6/kg, 6E6/kg), followed by an expansion study after determination of the RP2D.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

CN (1)