NCT06365671 CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors
| NCT ID | NCT06365671 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | B-cell Non Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2024-04-16 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 16 participants in total. It began in 2024-04-16 with a primary completion date of 2026-04.
⚠ 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
Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic Factors
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed B-cell non-Hodgkin's lymphoma including the following types * diffuse large B-cell lymphoma * high-grade B-cell lymphoma with or without MYC and BLC2 and/or BCL6 rearrangement * transformed lymphoma * primary mediastinal large B-cell lymphoma * follicular lymphoma (FL) 2. Relapsed or refractory diseases fulfilling one of the following criteria (individuals must have received anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy regimen) * Primary refractory disease, defined as disease progression after first-line immunochemotherapy or disease progression within 6 weeks of the end of the last chemotherapy * Stable disease (SD) as best response after at least 4 cycles of first-line therapy * Partial response (PR) as best response after at least 6 cycles of first-line therapy (biopsy-proven residual disease is needed for individuals with Deauville score of 4) * PR as best response after at least 2 cycles of second-line therapy * Disease relapse ≤12 months after the completion of first-line immunochemotherapy * Relapsed or refractory disease after ≥2 lines of chemotherapy 3. Presence of at least one of the following high-risk prognostic factors: (1) extranodal involvement; (2) maximum diameter of the bulky mass ≥5 cm; (3) TP53 gene alterations 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 5. Eligible for HDCT/ASCT based on the investigator's assessment and are scheduled to undergo an ASCT sequential CAR-T treatment regimen 6. Adequate renal and hepatic function defined as: * Serum alanine aminotransferase (ALT/AST) ≤ 3 upper limit of normal (ULN) * Total bilirubin ≤1.5 mg/dL(\<3 times ULN in patients with Gilbert's syndrome, cholestasis due to hepatoportal compression adenopathy, biliary obstruction in patients with liver involvement or lymphoma) * Serum creatinine ≤1.5 ULN, or creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min 7. Cardiac ejection fraction ≥ 40% 8. Baseline oxygen saturation \> 95% on room air 9. Life expectancy ≥3 months Exclusion Criteria: 1. History of autologous or allogeneic stem cell transplantation 2. Active HBV or HCV infection, defined as HBV-DNA or HCV-DNA levels above the normal upper limit, with or without abnormal liver function. Individuals with positive HBsAg or HBcAb should receive antiviral prophylaxis for at least 12 months after CAR-T cells infusion. 3. Presence of uncontrolled infection, cardio-cerebrovascular disease，coagulopathy, or connective tissue disease. 4. History of HIV infection 5. Prior chimeric antigen receptor cellular immunotherapy targeting CD19 6. Pregnant or lactating patients
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06365671 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying B-cell Non Hodgkin Lymphoma. 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 NCT06365671 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 NCT06365671 currently recruiting?
Yes, NCT06365671 is actively recruiting participants. Contact the research team at zwl_trial@163.com for enrollment information.
Where is the NCT06365671 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06365671 clinical trial?
NCT06365671 is sponsored by Ruijin Hospital. The trial plans to enroll 16 participants.