Recruiting NCT07344818
An Open and Dose-escalation Early Clinical Study of CD19 and CD20 CAR-T Cell Therapy for Relapsed or Refractory Aggressive B-cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CAR-T cell therapy.
- Who it may be relevant to
- Registry conditions: R/R Aggressive B-cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed description
In this study, anti-CD19 and anti-CD20 dual target CAR-T cell therapy will be explored for patients with relapsed/refractory aggressive B-cell lymphoma. In this study, the 3+3 dose climbing mode will be used to explore the safety and efficacy of dual-target CAR-T cells in r/r B-NHL therapy at different doses. The RP2D dose will be determined after the relevant data is summarized。
Interventions
- Biological CAR-T cell therapy
autologous CD19+CD20 dual CAR-T cells, single injection
Primary outcome measures
- the safety of CD19⁺CD20 CAR-T therapy [Time frame: 1 year after CAR-T cells therapy]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07344818 · CD19+CD20 dual CAR-T