CAR-T therapy after stem cell transplant for relapsed B-cell lymphoma
A Single-Arm Clinical Study of CD19 CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors
This study is testing if a new CAR-T therapy can help people with relapsed B-cell lymphoma feel better after they’ve had a stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | CAR-T, chimeric antigen receptor, chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06365671 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of Relmacabtagene autoleucel (relma-cel) infusion following high-dose chemotherapy and autologous stem-cell transplantation in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma who have high-risk prognostic factors. It is a single-center, open-label, prospective study that aims to assess the best complete response rate within three months, along with other response rates and the incidence of treatment-related toxicities. Participants will receive a fixed dose of relma-cel on day +3 after transplantation, and various safety and efficacy endpoints will be monitored throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed B-cell non-Hodgkin's lymphoma who have relapsed or refractory disease after prior treatments.
Not a fit: Patients with non-B-cell lymphomas or those who have not received prior anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with high-risk relapsed B-cell lymphoma.
How similar studies have performed: Other studies have shown promising results with CAR-T therapies in similar patient populations, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Weili Zhao
- Email: zwl_trial@163.com
- Phone: +862164370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.