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August 9, 2026Journal of Hematology & OncologyOpen Access

A phase 1 trial of CD123-directed chimeric antigen receptor T-cell therapy in adults with relapsed/refractory acute myeloid leukemia or blastic plasmacytoid dendritic cell neoplasm

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Authors

LBLihua E. BuddeMRMarissa M. Del RealJSJoo Song

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Overview

Randomized trial evaluates safety and anti-tumor activity of CD123 CAR T-cell therapy in adults, suggesting future optimization strategies.

Key Points

  • This trial aimed to assess the safety and anti-tumor activity of CD123-targeting CAR T cells in patients with relapsed/refractory AML or BPDCN.
  • Single center, open-label, phase 1 dose escalation design.
  • 41 patients enrolled with CD123-positive r/r AML or BPDCN, receiving either autologous or donor-derived CAR T cells.
  • Evaluated safety profiles and overall responses using predefined toxicity constraints.
  • 14 of 19 AML patients experienced grade ≤ 3 cytokine release syndrome.
  • 4 of 15 evaluable AML patients achieved complete remission, accounting for 26.7%.
  • No dose-limiting toxicity was observed, indicating a favorable safety profile.

Cite This Study

Budde et al. (2026) studied this question.

synapsesocial.com/papers/6a782d6e2e1896536c8406f6https://doi.org/10.1186/s13045-026-01833-3
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Effiefficacy and safety of allogeneic CD123 CAR-NK cell therapy in Relapsed/Refractory Acute Myeloid Leukemia2025 · 3 citations
  2. 2CD123-directed chimeric antigen receptor T-cell (CART123) therapy for relapsed/refractory pediatric acute myeloid leukemia2025
  3. 3Phase I study of functionally enhanced CD33 CAR T cells in patients with relapsed or refractory acute myeloid leukemia.2024 · 11 citations
  4. 4CLL-1 chimeric antigen receptor T-cells for the treatment of Acute Myeloid Leukemia: A phase 1 clinical trial2025 · 1 citations
  5. 5Abstract 1327: Affinity tuning anti-CD123 chimeric antigen receptor natural killer cell therapy to treat acute myeloid leukemia2024