Immunobridging/Maintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk R/R B-NHL
Recruiting now · Phase 2
Conditions studied: B-NHL, CART Therapy
In brief
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.
Key facts
- Study ID
- NCT06695013
- Run by
- Ruijin Hospital
- People needed
- 144
- Starts
- 2024-11-20
- Expected to finish
- 2027-03-20
- Last updated by the study team
- 2025-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Adequate organ function to assess tolerance to CAR-T therapy.
- Sufficient vascular access for leukapheresis.
- Ability to provide written informed consent and understand the study requirements and evaluation schedule.
- Fertile patients must agree to use highly effective contraception during the study and for 120 days post-treatment.
- Exclusion criteria：
- Patients with any of the following conditions will not be included in the study:
- 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%.
- Allergy to any investigational drug or excipient.
- Active viral hepatitis requiring treatment, including chronic HBV carriers with HBV DNA ≥ 500 IU/mL and positive HCV RNA.
- Active autoimmune disease or known history of allogeneic organ transplantation; long-term heavy use of immunosuppressants or other factors affecting study therapy.
- Active infection.
- History of uncontrolled systemic disease, such as diabetes or hypertension.
- Known HIV infection.
- Underlying medical condition or substance abuse that may interfere with drug administration or affect result interpretation, or increase treatment risk.
- End-organ damage from autoimmune disease within the past 2 years or systemic use of immunosuppressive drugs.
Where it is running
- Ruijin — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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