Actively Recruiting
A Single-arm, Open-label Clinical Study Evaluating the Efficacy and Safety of U01 (ssCART-19) in Patients With Relapsed or Refractory B-cell Lymphoma
Led by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Updated on 2026-05-06
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the efficacy and safety of U01 (ssCART-19), a CD19-targeted CAR-T cell therapy engineered with an IL-6 silencing element, in patients with relapsed or refractory B-cell lymphoma. The study is a single-arm, open-label clinical trial involving participants aged 2 to 75 years who have specific treatment histories and disease status as defined by clinical guidelines. The primary focus is to assess treatment responses and adverse events in this patient group. Participants will receive lymphodepletion preconditioning with cyclophosphamide and fludarabine over three consecutive days before infusion of the ssCART-19 cells. The study includes a treatment period where the experimental CAR-T cells are administered following the conditioning regimen. There are no comparator groups in this single-arm study, and the intervention is given under careful medical supervision. During the study, participants will be closely monitored for adverse events during the first 28 days after CAR-T cell infusion. Researchers will evaluate objective response rate, duration of response, overall survival, and progression-free survival up to two years post-infusion. Additional assessments include pharmacokinetics and pharmacodynamics of the ssCART-19 cells. Participants will undergo regular clinical evaluations, laboratory tests, and imaging to measure treatment effects and safety throughout the follow-up period extending up to two years.
CONDITIONS
Brief Title
Clinical Study of U01（ssCART-19） in Patients With B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent obtained with good compliance expected
- Age between 2 and 75 years at consent; both sexes eligible
- Histologically confirmed B-cell lymphoma per 2024 NCCN guidelines
- Prior therapy with anti-CD20 monoclonal antibody and anthracycline-containing regimen
- Failure to achieve partial remission after first-line therapy or relapse within 12 months; or relapsed/refractory after second-line therapy
- Ineligible for, refusal of, or relapse after autologous hematopoietic stem-cell transplantation
- Tumor tissue positive for CD19 by immunohistochemistry
- At least one measurable lesion per Lugano 2014 criteria
- ECOG performance status between 0 and 3
- Adequate marrow reserve and organ function as specified
- Negative pregnancy test for women of child-bearing potential and use of effective contraception
- Adequate venous access for leukapheresis
- Estimated life expectancy greater than 3 months
You will not qualify if you...
- Concurrent malignancy other than study indication except carcinoma in situ or disease-free malignancy over 3 years
- Positive viral infections with HBV, HCV, HIV, or syphilis above quantification limits
- Uncontrolled active infections including bacterial, fungal, viral, or mycoplasmal
- Clinically significant central nervous system disorders unrelated to lymphoma
- Significant cardiac history or conditions within 12 months prior to consent
- Known primary immunodeficiency
- History of severe immediate hypersensitivity to study drugs
- Receipt of any live vaccine within 6 weeks before screening
- Pregnant or breastfeeding women
- Active autoimmune disease requiring systemic immunosuppressive therapy
- Participation in another interventional clinical trial within 30 days prior to consent
- Any other condition deemed unsuitable by the investigator for study participation
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.
1 visit (in-person)
Duration - 3 days
Participants undergo lymphodepletion preconditioning with cyclophosphamide and fludarabine for 3 consecutive days before CAR-T cell therapy.
Daily visits for 3 days
Duration - 28 days post administration of ssCART-19
Participants receive CD19-targeted CAR-T cells engineered with an IL-6 silencing element as therapy for their B-cell lymphoma.
1 infusion visit and multiple follow-up visits during treatment period
Duration - Up to 2 years post CAR T cell infusion
Participants are monitored for efficacy and safety outcomes including response rate, survival, and pharmacokinetics for up to 2 years after CAR-T cell infusion.
Regular visits for assessments during follow-up period
Trial Site Locations
Total: 1 location
1
Tongji Hospital of Tongji University
Shanghai, China
Actively Recruiting
Research Team
W
Wenjun Zhang, Ph.D
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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