NCT06695013 Immunobridging/Maintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk R/R B-NHL
| NCT ID | NCT06695013 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | B-NHL |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2024-11-20 |
| Primary Completion | 2026-11-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 144 participants in total. It began in 2024-11-20 with a primary completion date of 2026-11-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Age 18 or older, regardless of gender. 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： Patients with any of the following conditions will not be included in the study: 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06695013 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying B-NHL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06695013 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06695013 currently recruiting?
Yes, NCT06695013 is actively recruiting participants. Contact the research team at zwl_trial@163.com for enrollment information.
Where is the NCT06695013 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06695013 clinical trial?
NCT06695013 is sponsored by Ruijin Hospital. The trial plans to enroll 144 participants.