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Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/Refractory B Cell Lymphoma

StatusRecruiting
PhasePhase 1
Started2023-12-31
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 28, 2023 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2023-12-21
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility v1
Eligibility criteria-13 characters
[...] y results showed positive CD19 expression; ECOG 0 ~ 1 points (Appendix 3); The expected survival time is 12 weeks or more; According [...] -dimensional measurable lesion as the evaluation basis: for intratodularintranodular lesion, it is defined as: long diameter >1.5cm; For extrano [...]
Secondary endpoints9 entries, revised
To evaluate the immunogenicity positive rate of MC-1-50 cell preparation after infusion
Primary endpoints2 entries, revised
Obtained the recommended doseIncidence of CARTreatment-TEmergent cellsAdverse forEvents the treatment of patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Safety and Tolerability] To evaluate the safety and tolerabilityIncidence of MCTreatment-1-50Emergent cellAdverse formulation in the treatment of CD19-positive relapsed/refractory B-cell non-Hodgkin lymphomaEvents [Safety and Tolerability]
Study title-10 characters
a Phase I Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/Refractory B Cell Lymphoma
2023-12-12
Original filing
This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B-cell non-Hodgkin lymphoma.
Trial Details
NCT Number NCT06180174
Lead Sponsor Chongqing Precision Biotech Co., Ltd
Collaborators: Peking University Cancer Hospital & Institute
Conditions B Cell Lymphoma, Non Hodgkin Lymphoma
Enrollment 24 participants
Start Date 2023-12-31
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2023-12-28