Actively Recruiting
Immunobridging and Maintenance Therapy Compared to No Bridging in CAR-T Treatment for Low-risk Relapsed or Refractory B-cell Non-Hodgkin Lymphoma A Multicenter, Randomized, Open-label Clinical Study
Led by Ruijin Hospital · Updated on 2025-01-24
144
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding immunotherapy as a bridging treatment before CAR-T therapy improves outcomes for patients with low-risk relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). This phase 2 study aims to identify the most effective treatment plan for these low-risk patients by comparing immunotherapy bridging and non-bridging approaches. The study focuses on patients who have not received prior CD19 CAR-T therapy and have adequate organ function for treatment.
CONDITIONS
Official 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 per Lugano criteria
- Relapsed or refractory after at least first-line treatment including chemotherapy with anthracyclines and anti-CD20 monoclonal antibody therapy
- No prior CD19 CAR T cell therapy
- Adequate organ function to tolerate CAR-T therapy
- Sufficient vascular access for leukapheresis
- Ability to provide written informed consent and understand study procedures
- Fertile patients agree to use effective contraception during study and for 120 days after treatment
You will not qualify if you...
- History of allogeneic hematopoietic stem cell transplantation
- History of epilepsy, cerebrovascular ischemia or bleeding, dementia, cerebellar disease, or autoimmune disease involving the central nervous system
- Other malignancies within past 2 years except cured cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder tumors
- Severe cardiovascular disease including NYHA grade II or above ischemia or infarction, poorly controlled arrhythmias, NYHA grade III-IV heart failure, or LVEF under 50%
- Allergy to any study drug or excipient
- Active viral hepatitis requiring treatment or chronic HBV carriers with high viral load, positive HCV RNA
- Active autoimmune disease, previous allogeneic organ transplant, or long-term heavy immunosuppressant use
- Active infection
- History of uncontrolled systemic disease like diabetes or hypertension
- Known HIV infection
- Medical conditions or substance abuse interfering with treatment or increasing risk
- End-organ damage from autoimmune disease in past 2 years or systemic immunosuppressive drug use
AI-Screening
AI-Powered Screening
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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
Frequently Asked Questions
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