NCT06987916 Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma
| NCT ID | NCT06987916 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shanghai Tongji Hospital, Tongji University School of Medicine |
| Condition | B Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2028-04-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2025-04-22 with a primary completion date of 2028-04-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 .
Eligibility Criteria
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: 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. 3. CD19 positivity confirmed by immunohistochemistry (IHC) of tumor tissue (preferably within 6 months). 4. At least one measurable lesion assessed by the Lugano Lymphoma Response Criteria (Cheson 2014) . 5. ECOG performance status score 0-3 . 6. Adequate bone marrow reserve at screening: Absolute lymphocyte count (ALC) ≥0.3×10⁹/L ; Platelet count (PLT) ≥30×10⁹/L . 7. 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 . 8. 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. 9. Adequate venous access for leukapheresis or blood collection, with no contraindications to leukapheresis. 10. Expected survival ≥3 months . 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; 5. 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; 6. Primary immunodeficiency ; 7. Severe immediate hypersensitivity to any study drug; 8. Live vaccine administration within 6 weeks prior to screening ; 9. Pregnancy or lactation ; 10. Active autoimmune diseases ; 11. Participation in another interventional clinical trial within 30 days prior to ICF signing ; 12. Other conditions deemed ineligible by the investigator.
Contact & Investigator
Wenjun Zhang, Doctor
PRINCIPAL INVESTIGATOR
Tongji hospital of tongji university (Shanghai tongji hospital)
Frequently Asked Questions
Who can join the NCT06987916 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 75 Years, studying B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06987916 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06987916 currently recruiting?
Yes, NCT06987916 is actively recruiting participants. Contact the research team at zhangwenjun@tongji.edu.cn for enrollment information.
Where is the NCT06987916 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06987916 clinical trial?
NCT06987916 is sponsored by Shanghai Tongji Hospital, Tongji University School of Medicine. The principal investigator is Wenjun Zhang, Doctor at Tongji hospital of tongji university (Shanghai tongji hospital). The trial plans to enroll 50 participants.