Actively Recruiting
A Single-Arm, Open-Label Study on the Safety and Efficacy of U01 (ssCART-19) in Treating Relapsed or Refractory B-Cell Lymphoma
Led by Shanghai Tongji Hospital, Tongji University School of Medicine · Updated on 2025-06-05
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of U01 (ssCART-19), a modified anti-CD19 CAR T-cell therapy, in patients with refractory or recurrent B-cell lymphoma. This open-label phase 1 and phase 2 study focuses on a new approach that uses small hairpin RNA technology to reduce IL-6 secretion, aiming to lower the risk of serious complications like cytokine release syndrome and neurotoxicity during CAR T-cell treatment. Participants will receive the ssCART-19 therapy, which involves autologous T cells modified to silence the IL-6 gene. All enrolled patients are treated with this experimental therapy as part of a single-arm study. The study follows patients over time to observe treatment response and monitor side effects closely. During the trial, participants will undergo regular assessments including safety monitoring from day 1 to week 4, and follow-up visits at 1, 3, 6, 9, 12, 18, and 24 months to evaluate response and survival outcomes. Researchers will also track CAR T-cell behavior and inflammatory marker levels in blood up to 3 months post-infusion. The total participation time may extend up to two years, with ongoing evaluations of health and disease status.
CONDITIONS
Brief Title
Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 2 to 75 years who voluntarily sign informed consent
- Confirmed diagnosis of B-cell lymphoma per NCCN guidelines
- Prior treatment failure or relapse after first- or second-line therapy including CD20 monoclonal antibody and anthracycline-based regimens
- Ineligible for, refusal of, or relapse after autologous stem cell transplantation
- CD19 positivity confirmed by tumor tissue testing
- At least one measurable lesion per Lugano criteria
- ECOG performance status 0 to 3
- Adequate bone marrow reserve with specified lymphocyte and platelet counts
- Adequate organ function meeting defined laboratory limits
- Negative pregnancy test for women of childbearing potential and agreement to use contraception
- Adequate venous access for leukapheresis or blood collection
- Expected survival of at least 3 months
You will not qualify if you...
- Concurrent malignancies except certain disease-free or in situ cancers
- Active viral infections including hepatitis B or C, syphilis, or HIV
- Uncontrolled infections as determined by the investigator
- Significant central nervous system diseases or autoimmune CNS disorders
- Recent cardiac procedures or significant cardiac history, including specific heart failure classes or abnormal heart function tests
- Primary immunodeficiency
- Severe immediate hypersensitivity to study drugs
- Live vaccine administration within 6 weeks prior to screening
- Pregnancy or lactation
- Active autoimmune diseases
- Participation in another interventional clinical trial within 30 days prior to consent
- Other conditions deemed ineligible by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Day 1
Participants receive a single infusion of ssCART-19, a modified anti-CD19 CAR T-cell therapy designed to reduce IL-6 secretion and associated complications.
1 treatment visit (in-person) for CAR T-cell infusion
Duration - Up to 24 months post-treatment
Participants are monitored for safety, treatment response, and survival outcomes after receiving the therapy.
Visits at 1, 3, 6, 9, 12, 18, and 24 months post-treatment for assessments
Trial Site Locations
Total: 1 location
1
Shanghai Tongji Hospital ( Tongji Hospital of Tongji University)
Shanghai, Shanghai Municipality, China, 200065
Actively Recruiting
Research Team
W
Wenjun Zhang, Doctor
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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