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Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma

A Single-Arm, Open-Label Clinical Study on the Efficacy and Safety of U01 (ssCART-19) in the Treatment of Relapsed or Refractory B-Cell Lymphoma

NCT06987916•Shanghai Tongji Hospital, Tongji University School of Medicine

View on ClinicalTrials.gov

Summary

This is an open-label phase1 study to assess the safety and efficacy of U01(ssCART-19) cell therapy in the treatment of patients with refractory or recurrent B-cell lymphoma .

Detailed Description

Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are critical complications in CAR T-cell therapy. Research highlights IL-6 as a central driver of CRS, as activated CAR T-cells secrete this cytokine, which in turn stimulates monocytes to produce additional IL-6. To mitigate this risk, ssCART-19-a modified anti-CD19 CAR T-cell therapy-incorporates small hairpin RNA (shRNA) technology to silence the IL-6 gene, thereby reducing IL-6 secretion by both CAR T-cells and monocytes. This study aims to assess the safety and efficacy of the U01 (ssCART-19) therapy in patients with refractory or recurrent B-cell lymphoma .

Eligibility

Age

2 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants must voluntarily sign the informed consent form (ICF) and demonstrate good compliance.
•2. Participants must meet the following requirements:
•1. Age ≥2 years and ≤75 years at the time of signing the ICF (both sexes eligible). For minors (\<18 years), the legal guardian must sign after full disclosure; minors with decision-making capacity must co-sign with their guardians.
•2. Confirmed diagnosis of B-cell lymphoma according to the NCCN Clinical Practice Guidelines for B-Cell Lymphomas (3rd Edition, 2024) .
•3. Prior treatment requirements :
•Failure to achieve partial response (PR) after first-line therapy, or relapse within 12 months post-first-line therapy; Relapsed/refractory B-cell lymphoma after second-line therapy (one standard chemotherapy regimen + one salvage regimen).
•Prior treatments must include CD20 monoclonal antibody (unless CD20-negative tumor confirmed by the investigator) and anthracycline-based regimens .
•Additionally, meet one of the following:
•i. Ineligible for autologous stem cell transplantation (ASCT); ii. Refusal of ASCT; iii. Post-ASCT relapse. d) Refractory/relapsed status at screening: Relapse: Disease progression (PD) after achieving PR or complete response (CR);
•Refractory:
+11 more criteria

Exclusion Criteria

•1. Concurrent malignancies , except for:
•Malignancies with disease-free survival (DFS) \>3 years ; Carcinoma in situ ;
•2. Active viral infections :
•Hepatitis B : Positive for HBe-Ab and/or HBc-Ab with HBV-DNA \> lower limit of quantitation (LLOQ) ; Hepatitis C : Positive HCV-Ab with HCV-RNA \> LLOQ ; Positive Treponema pallidum antibody (TP-Ab); Positive HIV antibody ;
•3. Uncontrolled infections (bacterial, fungal, viral, mycoplasmal, or others) as determined by the investigator;
•4. Clinically significant CNS diseases (current or history), including:
•Epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disorders, or CNS-related autoimmune diseases , deemed uncontrolled by the investigator;
•Cardiac angioplasty/stent placement within 12 months prior to signing ICF ; NYHA Class II-IV congestive heart failure , myocardial infarction, unstable angina, or other clinically significant cardiac history; QTe interval ≥480 ms (Fridericia correction) or LVEF \<50% at screening;
•6. Primary immunodeficiency ;
•7. Severe immediate hypersensitivity to any study drug;
+5 more criteria

Locations (1)

Shanghai Tongji Hospital ( Tongji Hospital of Tongji University)

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 22, 2025

Primary Completion Date

April 22, 2028

Completion Date

April 22, 2030

Last Updated

June 5, 2025

Enrollment

ESTIMATED participants

Conditions

B Cell Lymphoma

Interventions

ssCART-19

BIOLOGICAL

Contacts

Wenjun Zhang, Doctor

CONTACT

+86 13918803148 zhangwenjun@tongji.edu.cn

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RECRUITINGPHASE1

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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: June 5, 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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Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma

Inclusion Criteria

Exclusion Criteria

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