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Clinical Study of U01（ssCART-19） in Patients With B-Cell Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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.

NCT07093073•Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

View on ClinicalTrials.gov

Summary

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.

Detailed Description

The primary objective of this study is to evaluate the efficacy and safety of CD19-targeted CAR-T cells engineered with an IL-6 silencing element in patients with relapsed or refractory B-cell lymphoma.

Eligibility

Age

2 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
•• Relapse: progression after prior PR or CR.
•• Refractory: i. PD during/after last therapy, or best response ≤SD lasting \<6 months; OR ii. Relapse or progression after ASCT (biopsy-proven), including relapse/PD ≤12 months post-ASCT or lack of response (SD/PD) to salvage therapy after ASCT.
+9 more criteria

Exclusion Criteria

•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.
•9. Pregnant or breastfeeding women.
•10. Active autoimmune disease requiring systemic immunosuppressive therapy.
+2 more criteria

Locations (3)

Hebei Yanda Lu Daopei Hospital

Hebei, China

Tongji Hospital of Tongji University

Shanghai, China

Tianjin First Central Hospital

Tianjin, China

Key Dates

Start Date

January 23, 2025

Primary Completion Date

January 31, 2027

Completion Date

January 31, 2029

Last Updated

September 19, 2025

Enrollment

ESTIMATED participants

Conditions

B Cell Lymphoma

Interventions

ssCART-19

DRUG

Contacts

Wenjun Zhang, Ph.D

CONTACT

13918803148 zhangwenjun@tongji.edu.cn

Junfang Yang

CONTACT

13522084342 Yangjunfang77@163.com

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 more

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CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

NCT06026319

Non-hodgkin LymphomaRelapsed Non-Hodgkin Lymphoma+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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