Clinical Study of Multi-targeted CAR-T Therapy in Patients With Relapsed/Refractory B-Cell Lymphoma (NCT07093086) | Clinical Trial Compass
WithdrawnPhase 1
Clinical Study of Multi-targeted CAR-T Therapy in Patients With Relapsed/Refractory B-Cell Lymphoma
Stopped: The primary consideration is the allocation of company resources, and we have no choice but to terminate this research.
China0Started 2024-11-07
Plain-language summary
This is a single-arm, open-label clinical study evaluating the efficacy and safety of CD20/CD19/CD22 multi-targeted chimeric antigen receptor T-cell (CAR-T) injection in patients with relapsed/refractory B-cell lymphoma.
Who can participate
Age range2 Years – 75 Years
SexALL
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Inclusion criteria
✓. Voluntary written informed consent obtained from the participant (or legally authorized representative) with good compliance expected throughout the study.
✓. All of the following must be fulfilled:
✓. Age 2-75 years at the time of informed consent; both sexes eligible.For minors (≤18 years), consent must be provided by a parent or legal guardian; minors who are able to sign must co-sign with their guardian.
✓. Histologically confirmed B-cell lymphoma according to the NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas (2024 v3).
✓. Relapsed or refractory B-cell lymphoma after at least two prior lines of therapy (one standard chemo-regimen + one salvage regimen) that must have included:
✓. Tumor tissue (archival or fresh biopsy) positive for CD20 and/or CD19 and/or CD22 by immunohistochemistry (pathology report within 6 months preferred).
✓. ≥1 measurable lesion per Lugano 2014 (Cheson) criteria.
✓. ECOG performance status 0-3.
Exclusion criteria
✕. Concurrent malignancy other than the study indication. Exceptions: carcinoma in situ or any malignancy with disease-free survival ≥3 years.
✕. Use of immunosuppressive agents or systemic corticosteroids within 1 week before leukapheresis that, in the investigator's judgment, could substantially impair T-cell function.
✕
What they're measuring
1
Incidence of Adverse events after CAR-T cells infusion [Safety and Tolerability]
Timeframe: 28 days post administration of CAR-T-cells
2
Objective Response Rate (ORR), as assessed by Investigators
Timeframe: 2 years post CAR T cell infusion
3
Duration of response (DOR), as assessed by Investigators
Timeframe: 2 years post CAR T cell infusion
4
Progression-free survival (PFS), as assessed by Investigators
. 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 that, in the investigator's opinion, cannot be adequately controlled.
✕. Prior or current CNS disorders unrelated to lymphoma-e.g., seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any CNS autoimmune disease-deemed uncontrolled by the investigator.
✕. Within 12 months before informed consent: percutaneous coronary intervention (angioplasty or stent placement), or NYHA Class III-IV congestive heart failure, or history of myocardial infarction, unstable angina, or other clinically significant cardiac disease judged by the investigator. QTc interval \>480 ms (Fridericia correction), or left-ventricular ejection fraction \<50 % by echocardiography at screening.
✕. Known primary immunodeficiency.
✕. History of severe immediate hypersensitivity to any study-related drug.