RecruitingPhase 1

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

China30 participantsStarted 2025-01-23

Plain-language 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.

Who can participate

Age range2 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Voluntary written informed consent obtained from the participant (or legal guardian) with good compliance expected throughout the study.
✓. All of the following conditions must be met:
✓. 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.
✓. Histologically confirmed B-cell lymphoma per the 2024 v3 NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas.
✓. Prior therapy requirements:
✓. Tumor tissue (archival or fresh) positive for CD19 by IHC; pathology report within 6 months preferred.
✓. ≥1 measurable lesion per Lugano 2014 response criteria.
✓. ECOG performance status 0-3.

Exclusion criteria

✕. Concurrent malignancy other than the study indication, except for carcinoma in situ or any malignancy with a disease-free interval ≥3 years.
✕. 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.
✕. Active bacterial, fungal, viral, mycoplasmal, or other infection deemed uncontrollable by the investigator.
✕. 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.
✕. 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.
✕. Known primary immunodeficiency.
✕. History of severe immediate hypersensitivity to any study drug.
✕. Receipt of any live vaccine within 6 weeks before screening.

What they're measuring

Incidence of Adverse events after U01 CAR-T cells infusion [Safety and Tolerability]

Timeframe: 28 days post administration of ssCART-19

Objective Response Rate (ORR), as assessed by Investigators

Timeframe: 2 years post CAR T cell infusion

Duration of response (DOR)

Timeframe: 2 years post CAR T cell infusion

Overall survival (OS)

Timeframe: 2 years post CAR T cell infusion

Progression-free survival (PFS)

Timeframe: 2 years post CAR T cell infusion

Trial details

NCT IDNCT07093073

SponsorShanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

Wenjun Zhang, Ph.D

13918803148 zhangwenjun@tongji.edu.cn

View on ClinicalTrials.gov More B Cell Lymphoma trials

Who can participate

Age range2 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Voluntary written informed consent obtained from the participant (or legal guardian) with good compliance expected throughout the study.
✓. All of the following conditions must be met:
✓. 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.
✓. Histologically confirmed B-cell lymphoma per the 2024 v3 NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas.
✓. Prior therapy requirements:
✓. Tumor tissue (archival or fresh) positive for CD19 by IHC; pathology report within 6 months preferred.
✓. ≥1 measurable lesion per Lugano 2014 response criteria.
✓. ECOG performance status 0-3.

Exclusion criteria

✕. Concurrent malignancy other than the study indication, except for carcinoma in situ or any malignancy with a disease-free interval ≥3 years.
✕. 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.
✕. Active bacterial, fungal, viral, mycoplasmal, or other infection deemed uncontrollable by the investigator.
✕. 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.
✕. 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.
✕. Known primary immunodeficiency.
✕. History of severe immediate hypersensitivity to any study drug.
✕. Receipt of any live vaccine within 6 weeks before screening.

What they're measuring

Incidence of Adverse events after U01 CAR-T cells infusion [Safety and Tolerability]

Timeframe: 28 days post administration of ssCART-19

Objective Response Rate (ORR), as assessed by Investigators

Timeframe: 2 years post CAR T cell infusion

Duration of response (DOR)

Timeframe: 2 years post CAR T cell infusion

Overall survival (OS)

Timeframe: 2 years post CAR T cell infusion

Progression-free survival (PFS)

Timeframe: 2 years post CAR T cell infusion