Immunobridging/Maintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk R/R B-NHL
NCT ID: NCT06695013
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
144 participants
INTERVENTIONAL
2024-11-20
2027-03-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immunotherapy bridging treatment
Zanubrutinib ± radiotherapy was used as the bridging therapy in the immunobridging treatment group, a Follow-up maintenance treatment was determined according to the efficacy of D28 in the two groups. Patients with complete response (CR) were given no maintenance treatment, while patients with partial response (PR) were given Zanubrutinib orally plus PD-1 inhibitor for 2 years. Patients with stable SD or progressive PD were excluded from this study
zanubrutinib
zanubrutinib 160 mg BID orally
CAR-T
CAR-T Cell therapy
Bridging radiotherapy
For patients in the experimental group, the decision regarding radiotherapy will depend on whether the specific lesions are suitable.
Tislelizumab
200mg IV Q3-4W
no bridging treatment
The control group will not receive bridging treatment. Maintenance treatment will be consistent with the experimental group.
zanubrutinib
zanubrutinib 160 mg BID orally
CAR-T
CAR-T Cell therapy
Tislelizumab
200mg IV Q3-4W
Interventions
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zanubrutinib
zanubrutinib 160 mg BID orally
CAR-T
CAR-T Cell therapy
Bridging radiotherapy
For patients in the experimental group, the decision regarding radiotherapy will depend on whether the specific lesions are suitable.
Tislelizumab
200mg IV Q3-4W
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed B-cell non-Hodgkin lymphoma, according to Lugano diagnostic criteria.
3. At least first-line treatment for relapsed or refractory patients, including chemotherapy regimens containing anthracyclines and anti-CD20 monoclonal antibody therapy; patients must meet definitions of refractory and recurrent.
4. No prior CD19 CAR T cell therapy.
5. Adequate organ function to assess tolerance to CAR-T therapy.
6. Sufficient vascular access for leukapheresis.
7. Ability to provide written informed consent and understand the study requirements and evaluation schedule.
8. Fertile patients must agree to use highly effective contraception during the study and for 120 days post-treatment.
Exclusion Criteria
1. History of allogeneic hematopoietic stem cell transplantation.
2. History of epilepsy, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system.
3. Any other malignancies within the past 2 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors (Ta, Tis, and T1).
4. Severe cardiovascular disease: NYHA grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias; NYHA grade III to IV heart failure or left ventricular ejection fraction (LVEF) \< 50%.
5. Allergy to any investigational drug or excipient.
6. Active viral hepatitis requiring treatment, including chronic HBV carriers with HBV DNA ≥ 500 IU/mL and positive HCV RNA.
7. Active autoimmune disease or known history of allogeneic organ transplantation; long-term heavy use of immunosuppressants or other factors affecting study therapy.
8. Active infection.
9. History of uncontrolled systemic disease, such as diabetes or hypertension.
10. Known HIV infection.
11. Underlying medical condition or substance abuse that may interfere with drug administration or affect result interpretation, or increase treatment risk.
12. End-organ damage from autoimmune disease within the past 2 years or systemic use of immunosuppressive drugs.
18 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
Professor
Locations
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Ruijin
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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CLMB study
Identifier Type: -
Identifier Source: org_study_id
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