Clinical Trial

Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm

Completed Phase 1/2
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Summary
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of targeting CD123 CAR-NK cell preparations in Relapsed/refractory acute myeloid leukemia (AML) or blastocytic plasmacytoid dendritic cell neoplasm (BPDCN). The pharmacokinetic characteristics of CAR-NK cell preparations for the treatment of patients with Relapsed/refractory acute myeloid leukemia or blastocytic plasmacytoid dendritic cell neoplasm were obtained and the recommended dose.
Protocol Amendment History 4 changes
critical Trial completed 2026-08-06
notable Enrollment reduced: 36 -> 5 participants 2026-08-06
notable Primary completion moved earlier: 2025-12-31 -> 2025-09-25 2026-08-06
minor Completion moved earlier: 2026-08-31 -> 2025-12-31 2026-08-06
Trial Details
NCT Number NCT06006403
Lead Sponsor Chongqing Precision Biotech Co., Ltd
Collaborators: Shanxi Bethune Hospital
Conditions Acute Myeloid Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Relapse Leukemia, Refractory Leukemia
Enrollment 5 participants
Start Date 2024-03-28
Primary Completion 2025-09-25 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-05