Status:
RECRUITING
Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma
Lead Sponsor:
Shanghai Tongji Hospital, Tongji University School of Medicine
Conditions:
B Cell Lymphoma
Eligibility:
All Genders
2-75 years
Phase:
PHASE1
PHASE2
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 .
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...
Eligibility Criteria
Inclusion
- 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:
- Absolute lymphocyte count (ALC) ≥0.3×10⁹/L ; Platelet count (PLT) ≥30×10⁹/L .
- Adequate organ function:
- AST/ALT ≤3×ULN (≤5×ULN if due to tumor infiltration); Total bilirubin ≤2×ULN (≤3×ULN for Gilbert syndrome with direct bilirubin ≤1.5×ULN); Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula); Oxygen saturation \>91% on room air (dyspnea grade ≤1); Left ventricular ejection fraction (LVEF) ≥50% ; INR ≤1.5×ULN and APTT ≤1.5×ULN .
- Negative pregnancy test (blood/urine) within 7 days before CAR-T infusion for women of childbearing potential. All participants must agree to use effective contraception during the study and for ≥1 year post-treatment.
- Adequate venous access for leukapheresis or blood collection, with no contraindications to leukapheresis.
- Expected survival ≥3 months .
Exclusion
- 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;
- Cardiovascular exclusion criteria :
- 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.
Key Trial Info
Start Date :
April 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 22 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06987916
Start Date
April 22 2025
End Date
April 22 2030
Last Update
June 5 2025
Active Locations (1)
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1
Shanghai Tongji Hospital ( Tongji Hospital of Tongji University)
Shanghai, Shanghai Municipality, China, 200065