1. Flotetuzumab as a salvage immunotherapy in advanced CD123-positive hematological malignancies, a phase 1 pilot study.
- Author
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Aldoss, Ibrahim, Zhang, Jianying, Robbins, Marjorie, Song, Joo, Al Malki, Monzr M., Otoukesh, Salman, Sandhu, Karamjeet, Agrawal, Vaibhav, Herrera, Alex F., Popplewell, Leslie L., Ghoda, Lucy, Stein, Anthony, Marcucci, Guido, Forman, Stephen, and Pullarkat, Vinod
- Subjects
HEMATOLOGIC malignancies ,HODGKIN'S disease ,CYTOKINE release syndrome ,IMMUNOTHERAPY ,CANCER remission - Abstract
CD123 "expression" is common in hematological malignancies, including acute lymphoblastic leukemia (ALL). Flotetuzumab is a novel, investigational CD3/CD123 DART®. We conducted a phase 1 study evaluating safety and efficacy of flotetuzumab in relapsed/refractory ALL (Cohort A) and other advanced CD123-positive hematological malignancies (excluding myeloid malignancies) (cohort B). Thirteen patients (9 in Cohort A and 4 in Cohort B) were treated at dose level 1 (500 ng/kg/day) before early closure due to discontinuation of drug development by sponsor. Two dose limiting toxicities (Grade 4 thrombocytopenia and neutropenia) occurred in one patient in Cohort B. Cytokine release syndrome occurred in most patients (85%), all being grade ≤2. Responses only occurred in Cohort B, with a partial response in one patient with Hodgkin's lymphoma and morphological complete remission in the bone marrow in one patient with blastic plasmacytoid dendritic cell neoplasm. In conclusion, flotetuzumab had a manageable safety profile in advanced CD123-positive hematological malignancies. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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