Actively Recruiting
Clinical Study of U01（ssCART-19） in Patients With B-Cell Lymphoma
Led by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Updated on 2026-05-06
30
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is 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.
CONDITIONS
Official 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 expected good compliance.
- Age between 2 and 75 years at consent; both sexes eligible; minors require parental/legal guardian consent.
- Histologically confirmed B-cell lymphoma as per 2024 NCCN guidelines.
- Prior therapy with anti-CD20 monoclonal antibody and anthracycline-containing regimen.
- Failure to achieve partial response after first-line therapy or relapse within 12 months after first-line therapy; or relapsed/refractory after second-line therapy.
- Ineligible for, refusing, or relapsed after autologous hematopoietic stem-cell transplantation.
- Disease status: relapse with progression after prior response or refractory disease as defined.
- Tumor tissue positive for CD19 by immunohistochemistry.
- At least one measurable lesion according to Lugano 2014 criteria.
- ECOG performance status between 0 and 3.
- Adequate marrow reserve with specified lymphocyte and platelet counts.
- Adequate organ function including liver enzymes, bilirubin, kidney function, lung function, heart function, and coagulation parameters.
- Negative pregnancy test for women of child-bearing potential; use of effective contraception through 12 months post-infusion.
- Adequate venous access for leukapheresis or repeated blood draws.
- Estimated life expectancy greater than 3 months.
You will not qualify if you...
- Presence of any other active malignancy except carcinoma in situ or malignancy disease-free for 3 years or more.
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV with viral loads above quantification limits.
- Uncontrollable active infections including bacterial, fungal, viral, or mycoplasmal.
- History or current significant central nervous system disorders unrelated to lymphoma.
- Recent serious cardiac events or conditions within 12 months prior to consent.
- QTc interval greater than 480 ms or left ventricular ejection fraction below 50% at screening.
- Known primary immunodeficiency.
- History of severe allergic reaction to any study drug.
- Receipt of any live vaccine within 6 weeks before screening.
- Pregnant or breastfeeding women.
- Active autoimmune diseases requiring systemic immunosuppressive treatment.
- Participation in another interventional clinical trial within 30 days prior to consent.
- Any condition deemed by the investigator to make the subject unsuitable for study participation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital of Tongji University
Shanghai, China
Actively Recruiting
Research Team
W
Wenjun Zhang, Ph.D
CONTACT
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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