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New treatment option for R/R Aggressive B-cell Lymphoma
Official title An Open and Dose-escalation Early Clinical Study of CD19 and CD20 CAR-T Cell Therapy for Relapsed or Refractory Aggressive B-cell Lymphoma
ClinicalTrials.gov ID: NCT07344818
What this study is testing
What is CAR-T cell therapy?
CAR-T cell therapy is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for r/r aggressive b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The subject or his/her legal guardian is able to understand and voluntarily sign the informed consent form (ICF).
- Male or female people 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. people must have previously received treatment with...
You likely can't join 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...
- Evidence of active infection, including: HBV DNA、Positive anti-HCV antibody with detectable HCV RNA、Positive HIV antibody、Positive cytomegalovirus...
- Clinically significant cardiovascular disease.
See the full eligibility criteria
- The subject or his/her legal guardian is able to understand and voluntarily sign the informed consent form (ICF).
- Male or female people 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. people must have previously received treatment with anthracycline-containing chemotherapy and rituximab (or other...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.