Actively Recruiting
Immunobridging/Maintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (R/R B-NHL): A Multicenter, Prospective, Randomized, Open-label, Controlled Clinical Study
Led by Ruijin Hospital · Updated on 2025-01-24
144
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find out if adding immunotherapy as a bridging treatment before CAR-T therapy can improve results for patients with low-risk relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). The study compares immunotherapy bridging treatment against no bridging treatment to identify the best approach for low-risk patients. It is a Phase 2, multicenter, randomized, open-label clinical trial sponsored by Ruijin Hospital. Participants in the immunotherapy bridging group will receive zanubrutinib, with or without radiotherapy depending on lesion suitability, before CAR-T therapy. The group without bridging treatment will not receive these medications. After 28 days, patients who show a complete response will not have maintenance therapy, while those with a partial response will receive oral zanubrutinib plus a PD-1 inhibitor for two years. Patients with stable or progressive disease are not included in the study. During the trial, participants will be monitored at 28 days and three months after CAR-T infusion to assess response rates. Researchers will also follow patients for two years to evaluate survival, disease progression, CAR-T cell levels, and side effects. Assessments include physical exams, laboratory tests, and imaging to track treatment effects and safety. This detailed follow-up helps determine the most effective treatment plan for low-risk B-NHL patients.
CONDITIONS
Brief Title
Immunobridging/Maintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk R/R B-NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older, any gender
- Histologically confirmed B-cell non-Hodgkin lymphoma according to Lugano criteria
- Relapsed or refractory disease after at least first-line treatment including anthracycline chemotherapy and anti-CD20 antibody therapy
- No previous CD19 CAR T cell therapy
- Adequate organ function to tolerate CAR-T therapy
- Sufficient vascular access for leukapheresis
- Ability to understand and provide written informed consent
- Fertile patients agree to use effective contraception during the study and for 120 days after treatment
You will not qualify if you...
- History of allogeneic hematopoietic stem cell transplantation
- History of epilepsy, cerebrovascular events, dementia, cerebellar disease, or central nervous system autoimmune diseases
- Other cancers within past 2 years except cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors
- Severe cardiovascular disease including NYHA grade II or higher ischemia, myocardial infarction, uncontrolled arrhythmias, or NYHA III-IV heart failure with LVEF below 50%
- Allergy to any study drug or excipient
- Active viral hepatitis requiring treatment or high viral load chronic HBV or HCV infection
- Active autoimmune disease or history of organ transplantation or long-term immunosuppressant use
- Active infection
- Uncontrolled systemic disease such as diabetes or hypertension
- Known HIV infection
- Medical conditions or substance abuse interfering with treatment or increasing risk
- Organ damage from autoimmune disease or systemic immunosuppressive drugs within past 2 years
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days before CAR-T infusion
Participants in the immunotherapy bridging group receive zanubrutinib with or without radiotherapy as a bridging treatment before CAR-T therapy.
Visits as needed during bridging period
Duration - Single treatment event
Participants receive CAR-T cell therapy for their relapsed or refractory B-cell non-Hodgkin lymphoma.
1 infusion visit
Duration - 1 day assessment
Participants are assessed 28 days after CAR-T infusion to determine response and guide maintenance therapy decisions.
1 visit (in-person)
Duration - Up to 2 years
Participants with partial response receive oral zanubrutinib plus PD-1 inhibitor (tislelizumab) as maintenance therapy for up to 2 years.
Tislelizumab IV every 3 to 4 weeks and oral zanubrutinib twice daily; visit frequency approximately every 3 to 4 weeks
Duration - Up to 2 years post CAR-T infusion
Participants are monitored for up to 2 years after CAR-T infusion for treatment response, survival, and adverse events.
Regular follow-up visits approximately every 3 to 4 weeks during maintenance and periodic assessments thereafter
Trial Site Locations
Total: 1 location
1
Ruijin
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Z
zhao wei li, doctor Degree
Y
yan zi xun, doctor degree
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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