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Recruiting Early Phase 1

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

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About this study

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

Condition
R/R Aggressive B-cell Lymphoma
Tested
CAR-T cell therapy
Sponsor
Peking University People's Hospital

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 12

  • Minimum age: 18 years
  • Study condition: R/R Aggressive B-cell Lymphoma
  • 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.

Exclusion 16

  • 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.
  • Pregnant or breastfeeding women.

Where

1 site, 1 recruiting

Peking University People's Hospital

Beijing, Beijing Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.