Clinical Study of U01（ssCART-19） in Patients With B-Cell Lymphoma
ConditionB Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-75
SponsorShanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary written informed consent obtained from the participant (or legal guardian) with good compliance expected throughout the study.
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.
Failure to achieve PR after first-line therapy, OR relapse within 12 months after first-line therapy; or Relapsed/refractory after second-line therapy (one standard chemo-regimen + one salvage regimen).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
ssCART-19
DrugLymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: U01(ssCART-19) CAR-T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Adverse events after U01 CAR-T cells infusion [Safety and Tolerability]
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Time frame
28 days post administration of ssCART-192
Objective Response Rate (ORR), as assessed by Investigators
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Remission (CR) or Partial Remission(PR)
Time frame
2 years post CAR T cell infusion3
Duration of response (DOR)
Duration of response (DOR) is defined as the time from the first documented objective response to the first documented disease progression or death.
Time frame
2 years post CAR T cell infusion4
Overall survival (OS)
Overall Survival (OS) was defined as the time from the date of first infusion of U01 to the date of death due to any cause.
Time frame
2 years post CAR T cell infusionSecondary outcomes
1
Pharmacokinetics of ssCART-19
Time at the maximal concentration(Tmax)
Time frame
2 years post CAR T cell infusion2
Pharmacokinetics of ssCART-19
Area under the concentration-time curve(AUC)
Time frame
2 years post CAR T cell infusion3
Pharmacokinetics of ssCART-19
The maximal concentration of peripheral blood (Cmax)
Time frame
2 years post CAR T cell infusion4
Pharmacodynamics of ssCART-19
Concentration levels of CAR-T-related serum cytokines such as IL-6, IFN γ, ferritin and CRP at each time point
Time frame
2 years post CAR T cell infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov