Immunobridging/Maintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk R/R B-NHL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
This study aims to explore whether adding immunotherapy bridging treatment for low-risk refractory/relapsed B-NHL can demonstrate better outcomes, in order to find the most effective treatment plan for low-risk patients.
Eligibility criteria
Qualifiers
Age 18 or older, regardless of gender.
Histologically confirmed B-cell non-Hodgkin lymphoma, according to Lugano diagnostic criteria.
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.
No prior CD19 CAR T cell therapy.
Disqualifiers
History of allogeneic hematopoietic stem cell transplantation.
History of epilepsy, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system.
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).
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%.
Trial design
Treatments tested in this trial
- zanubrutinib
- CAR-T
- Bridging radiotherapy
- Tislelizumab
Treatment groups
144 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov