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

NCT06987916 | Recruiting Phase 1

• 1 other identifier: U01-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

B Cell Lymphoma

Keywords

ssCART-19; Relapsed or Refractory B-Cell Lymphma; IL-6

Outcome Measures

Primary Outcomes (5)

• The types, frequency, and severity of treatment related adverse events

  After CAR-T cell infusion, we will observe the potential adverse events, especially Cytokine Release Syndrome(CRS) and neurotoxicity Using NCI Common Terminology Criteria for Adverse Events(CTCAE) V5.0

  Day1 to Week 4

• Objective response rate(ORR)

  At 1,3,6,9,12,18 and 24 months post-treatment follow up

• Duration of response (DOR)

  At 1,3,6,9,12,18 and 24 months post-treatment follow up

• Progression free survival(PFS)

  At 1,3,6,9,12,18 and 24 months post-treatment follow up

• Overall survival(OS)

  At 1,3,6,9,12,18 and 24 months post-treatment follow up

Secondary Outcomes (2)

• Kinetics of CAR-T cells

  Day1 to Month 3

• Monitoring changes in IL-6, ferritin, and CRP in peripheral blood following CAR-T cell infusion

  Day1 to Month 3

Study Arms (1)

ssCART-19

EXPERIMENTAL

All enrolled patients in this arm will receive ssCART-19

Biological: ssCART-19

Interventions

ssCART-19 BIOLOGICAL

autologous T cells transduced with a lentiviral vector containing anti-CD19 CAR and small hairpin RNA to silence the IL-6 gene

Also known as: anti-CD19 CAR T with small hairpin RNA to silence the IL-6 gene

ssCART-19

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must voluntarily sign the informed consent form (ICF) and demonstrate good compliance.
• Participants must meet the following requirements:
• 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.
• Confirmed diagnosis of B-cell lymphoma according to the NCCN Clinical Practice Guidelines for B-Cell Lymphomas (3rd Edition, 2024) .
• 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:
• i. No response to last-line therapy (PD during/after treatment, or stable disease \[SD\] lasting \<6 months); ii. Post-ASCT relapse/PD (biopsy-confirmed), including relapse/PD within 12 months post-ASCT with SD/PD after salvage therapy2.
• CD19 positivity confirmed by immunohistochemistry (IHC) of tumor tissue (preferably within 6 months).
• At least one measurable lesion assessed by the Lugano Lymphoma Response Criteria (Cheson 2014) .
• ECOG performance status score 0-3 .
• Adequate bone marrow reserve at screening:

You may not qualify if:

• Concurrent malignancies , except for:
• Malignancies with disease-free survival (DFS) \>3 years ; Carcinoma in situ ;
• 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 ;
• Uncontrolled infections (bacterial, fungal, viral, mycoplasmal, or others) as determined by the investigator;
• 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;
• Primary immunodeficiency ;
• Severe immediate hypersensitivity to any study drug;
• Live vaccine administration within 6 weeks prior to screening ;
• Pregnancy or lactation ;
• Active autoimmune diseases ;
• Participation in another interventional clinical trial within 30 days prior to ICF signing ;
• Other conditions deemed ineligible by the investigator.

Sponsors & Collaborators

• Shanghai Tongji Hospital, Tongji University School of Medicine: lead

Study Sites (1)

Shanghai Tongji Hospital ( Tongji Hospital of Tongji University)

Shanghai, Shanghai Municipality, 200065, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Recurrence

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenjun Zhang, Doctor

  Tongji hospital of tongji university (Shanghai tongji hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjun Zhang, Doctor

CONTACT

+86 13918803148; zhangwenjun@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): April 22, 2028
• Study Completion (Estimated): April 22, 2030
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)