Actively Recruiting
A Single-Arm Clinical Study of CD19 CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma With High-Risk Prognostic Factors
Led by Ruijin Hospital · Updated on 2026-01-06
16
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CD19 CAR-T cell therapy after high-dose chemotherapy and autologous stem-cell transplantation (ASCT) in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (B-NHL) who have high-risk factors such as extranodal involvement, bulky tumors, or TP53 gene alterations. This single-arm, open-label clinical trial aims to understand treatment outcomes including response rates and side effects. Participants will receive high-dose chemotherapy followed by an infusion of their own stem cells to restore bone marrow function. Then, on about day 3 after transplantation, they will receive a fixed dose of 100 million CD19 CAR-T cells. This combination approach is being studied to determine its impact on disease control and patient safety. During the study, participants will be closely monitored with assessments to measure the best complete response rate at 3 months after CAR-T infusion, as well as other outcomes like overall survival and progression-free survival over 2 years. Researchers will also track side effects such as cytokine release syndrome, neurotoxicity, and other treatment-related toxicities. The total study duration includes at least two years of follow-up to evaluate long-term effects and safety.
CONDITIONS
Brief Title
CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed B-cell non-Hodgkin's lymphoma including 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, or follicular lymphoma
- Relapsed or refractory disease meeting specific criteria after prior anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy
- Presence of at least one high-risk factor: extranodal involvement, bulky mass 65 cm in diameter, or TP53 gene alterations
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Eligible for high-dose chemotherapy and autologous stem-cell transplantation as assessed by the investigator
- Adequate kidney and liver function with specific laboratory values
- Cardiac ejection fraction of at least 40%
- Baseline oxygen saturation above 95% on room air
- Life expectancy of at least 3 months
You will not qualify if you...
- History of autologous or allogeneic stem cell transplantation
- Active hepatitis B or C infection with elevated viral DNA levels
- Uncontrolled infection, cardiovascular or cerebrovascular disease, coagulopathy, or connective tissue disease
- History of HIV infection
- Prior chimeric antigen receptor cellular immunotherapy targeting CD19
- Pregnant or breastfeeding patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 months post CAR-T infusion
Participants receive high-dose chemotherapy followed by autologous stem-cell transplantation, then receive a fixed dose of CD19 CAR-T cell infusion on day 3 (±1 day) after transplantation.
1 transplantation procedure and 1 CAR-T infusion visit, with additional visits during the 3 months following infusion
Duration - Up to 2 years post CAR-T infusion
Participants are monitored for safety and efficacy outcomes including response rates, survival, and adverse events.
Regular visits over 2 years for assessments
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
W
Weili Zhao
L
Li Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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