PRELIMINARY DATA FROM A FIRST‐IN HUMAN PHASE II STUDY OF SEQUENTIAL USE OF SELINEXOR AND CD19 CART THERAPY IN PATIENTS WITH RELAPSED OR REFRACTORY B‐CELL NON‐HODGKIN LYMPHOMA
نویسندگان
چکیده
Background: Preclinical trial has demonstrated that sequential use of Selinexor and Anti-CD19 directed chimeric antigen receptor modified T-Cell therapy (CART19) cells might improve the anti-tumor efficacy CART 19 against lymphoma cells. However, safety CART19 combined with in patients is unknown. We report preliminary data from a phase 2 relapsed or refractory B-cell non-Hodgkin (R/R B-NHL). Methods: performed multicenter, prospective, II, open-label clinical study R/R B-NHL. Patients received as bridging (40–60 mg) weekly for three weeks prior to infusion. Over all response (ORR), duration (DOR) were evaluated primary objectives. This registered ClinicalTrials.gov, NCT05322330. Results: Between February 10, 2022, 2023, 6 enrolled. Four diffuse large lymphoma, one mantle cell Burkitt 40mg treatment. The median age was 55.5 years (range 34–77), 3 (50.0%) had disease, 5 (83.3%) extranodal involvement systemic 2–5), LDH administration. Median on-study follow-up 9.68 months 2.53–12.17). 4 (66.7%) an overall response. Cytokine release syndrome (CRS) most common adverse event, occurring (100.0%) [66.7% grade 1–2 33.3% 3]. No neurotoxicity observed. 3–4 events neutropenia (5 [83.3%] patients), thrombocytopenia (4 [66.7%]), anemia (3 [50.0%]). treatment-related event occurred. Furthermore, our showed resulted higher proportion CD8+central memory T phenotypes (P = 0.04) while having no effect on CD4+ central (Figure 1). Encore Abstract - previously submitted ASCO 2023 Keywords: Cellular therapies, Combination Therapies, Ongoing Trials conflicts interests pertinent abstract.
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ژورنال
عنوان ژورنال: Hematological Oncology
سال: 2023
ISSN: ['1099-1069', '0278-0232']
DOI: https://doi.org/10.1002/hon.3165_633