Exploratory Study of CD19-targeted Chimeric Antigen Receptor T Cells(BZ019) for Relapsed and Refr… (NCT04067414) | Clinical Trial Compass
CompletedPhase 1
Exploratory Study of CD19-targeted Chimeric Antigen Receptor T Cells(BZ019) for Relapsed and Refractory B-cell Lymphoma
China12 participantsStarted 2018-06-08
Plain-language summary
This is an open-label, multicenter, dose-escalation phase 1 study to determine the safety and efficacy of BZ019 in relapsed or refractory CD19+ B-cell Lymphoma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent must be obtained prior to any screening procedures
✓. Age ≥ 18 years subjects with Relapsed or refractory large B-cell lymphoma, including: DLBCL,NOS, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, transformed B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBCL).
✓. Subjects must be accepted adequate treatment, including at least:
✓. Measurable disease at time of enrollment according to the revised international working group response criteria for malignant lymphoma.
✓. Life expectancy ≥12 weeks
✓. Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening.
✓. Adequate organ function:
✓. Hemodynamically stable and Left Ventricle Ejection Fraction (LVEF) ≥ 45% confirmed by echocardiogram or Multigated Radionuclide Angiography (MUGA)
Exclusion criteria
✕. Prior treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy
✕. Treatment with any prior gene therapy product, include CAR-T cell therapy.
✕. Active Central Nervous System (CNS) involvement by malignancy or secondary CNS involvement
✕. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or self-immune disease with CNS involvement.
What they're measuring
1
Number of adverse events
Timeframe: up to 1 year after BZ019 infusion.
Trial details
NCT IDNCT04067414
SponsorInstitute of Hematology & Blood Diseases Hospital, China