Dual CD19 and CD20 CAR-T therapy for relapsed or refractory aggressive B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, early phase 1 trial tests autologous CAR-T cells engineered to recognize both CD19 and CD20 in adults with relapsed or refractory aggressive B-cell lymphoma. A 3+3 dose-escalation design is used to evaluate safety and preliminary anti-tumor activity and to determine a recommended phase 2 dose (RP2D). Eligible patients must have received prior anthracycline-containing chemotherapy and anti-CD20 therapy and have measurable disease with tumor expression of CD19 and/or CD20. Treatments, infusions, and early safety monitoring (including assessments for cytokine release syndrome and neurotoxicity) will be conducted at the enrolling hospital in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The subject or his/her legal guardian is able to understand and voluntarily sign the informed consent form (ICF).
2. Male or female subjects aged ≥18 years at the time of signing the ICF.
3. An expected life expectancy of at least 12 weeks.
4. An ECOG performance status of 0-2 at the time of signing the ICF.
5. 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).
6. Presence of measurable positive lesions as defined by the Lugano criteria.
7. Lymphoma lesions confirmed by biopsy to screening demonstrating expression of CD19 and/or CD20.
8. Adequate major organ function.
9. contraception.

Exclusion Criteria:

1. Lymphoma involving only the central nervous system (CNS) (except for secondary CNS lymphoma).
2. History of CNS disorders.
3. History of autoimmune disease requiring systemic immunosuppressive therapy within 4 weeks prior to signing the ICF.
4. 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.
5. 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.
6. Clinically significant cardiovascular disease.
7. Known hypersensitivity to any component of the investigational products used in this study.
8. Receipt of any disease-related investigational therapy or other systemic antitumor therapy prior to leukapheresis and within 5 half-lives of the drug.
9. 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.
10. Major surgery (excluding routine biopsy) within 4 weeks prior to signing the ICF, or planned major surgery during the study period.
11. History of another primary malignancy within 5 years prior to signing the ICF, except for:

    1. Adequately treated and cured carcinoma in situ of the cervix;
    2. Localized basal cell carcinoma or squamous cell carcinoma of the skin.
12. 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.
13. Any condition or complication that, in the investigator's opinion, may affect protocol compliance or make the subject unsuitable for participation in the study.
14. Pregnant or breastfeeding women.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaodong Mo, PhD
• Email: mxd453@163.com
• Phone: (86)010-88325531

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

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• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

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• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

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• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

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  Recruiting at 4 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06925464

• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

  This study is testing if a combination of golcadomide and rituximab can help patients with aggressive B-cell lymphoma get ready for CAR T-cell therapy.

  Recruiting at 7 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 6 other locations · NCT06834373

• Loncastuximab tesirine plus rituximab as bridging therapy before CAR-T for relapsed or refractory large B‑cell lymphoma

  This trial tries loncastuximab tesirine with rituximab as a bridge before commercial CD19 CAR‑T therapy for adults with relapsed or refractory large B‑cell lymphoma to see if it is safe and helps control disease before CAR‑T.

  Recruiting at 2 sites Phase 2 University of Utah · Chapel Hill, North Carolina and 1 other locations · NCT06788964

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.