RecruitingB Cell Lymphoma

Clinical Study of U01（ssCART-19） in Patients With B-Cell Lymphoma

Eligible age

2–75 yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

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About this study

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.

Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

You may qualify if…

✓ 1. Voluntary written informed consent obtained from the participant (or legal guardian) with good compliance expected throughout the study.
✓ 2. All of the following conditions must be met:
✓ 1. Age 2-75 years at informed consent; both sexes eligible. For minors (≤18 years), consent must be provided by a parent/legal guardian; minors able to sign must co-sign with their guardian.
✓ 2. Histologically confirmed B-cell lymphoma per the 2024 v3 NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas.
✓ 3. Prior therapy requirements:
✓ Failure to achieve PR after first-line therapy, OR relapse within 12 months after first-line therapy; or Relapsed/refractory after second-line therapy (one standard chemo-regimen + one salvage regimen).
✓ Prior regimens must have included anti-CD20 monoclonal antibody (unless documented CD20-negative tumor) and an anthracycline-containing regimen. In addition, at least one of the following must apply:
✓ i. Ineligible for autologous hematopoietic stem-cell transplantation (ASCT); ii. Refusal of ASCT; iii. Relapse after ASCT. d) Disease status at screening:

You may not qualify if…

✕ 1. Concurrent malignancy other than the study indication, except for carcinoma in situ or any malignancy with a disease-free interval ≥3 years.
✕ 2. Presence of any of the following:• Positive HBe-Ab and/or HBc-Ab with HBV-DNA above the lower limit of quantification;• Positive HCV-Ab with HCV-RNA above the lower limit of quantification;• Positive Treponema pallidum antibody (TP-Ab);• Positive HIV antibody.
✕ 3. Active bacterial, fungal, viral, mycoplasmal, or other infection deemed uncontrollable by the investigator.
✕ 4. History or current clinically significant CNS disorder unrelated to lymphoma-e.g., seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any CNS autoimmune disease-that the investigator considers uncontrolled.
✕ 5. Within 12 months before informed consent: percutaneous coronary intervention (angioplasty or stent placement), NYHA Class III-IV congestive heart failure, myocardial infarction, unstable angina, or other clinically significant cardiac history judged by the investigator; or QTc \>480 ms (Fridericia correction) or LVEF \<50 % by echocardiography at screening.
✕ 6. Known primary immunodeficiency.
✕ 7. History of severe immediate hypersensitivity to any study drug.
✕ 8. Receipt of any live vaccine within 6 weeks before screening.

Source: ClinicalTrials.gov · NCT07093073 · last updated 2026-05-06