A Phase 1 interventional study of KW-2478 in Multiple Myeloma, Chronic Lymphocytic Leukaemia and B-cell Non-Hodgkin's Lymphoma, sponsored by Kyowa Kirin Co., Ltd.. Completed at 6 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-25.
Sponsored by Kyowa Kirin Co., Ltd. · Phase 1, Interventional, and Treatment
The aim of this study is to determine the safety, tolerability and dose-limiting toxicities of KW-2478 and to determine the Maximum Tolerated Dose and recommended Phase II dose for patients with relapsed/refractory MM, CLL or B-cell NHL.
This is a Phase I, open-label, dose-escalation study of KW-2478 in patients with relapsed/refractory multiple myeloma, chronic lymphocytic leukaemia or B-cell Non-Hodgkin's lymphoma who have no established therapeutic alternatives. Up to 42 patients will be enrolled at up to six investigational sites over a period of approximately 12 months until an MTD is reached. An additional 12 patients may be enrolled at the MTD in an expanded cohort of one or more of the eligible conditions.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 27 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous KW-2478 (ascending dose cohorts)
Drug: KW-2478
Daily intravenous KW-2478 for 5 days in 14-day cycles, ascending dose cohorts
To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II dose
Time frame: At every visit and at the end of each 14-day treatment cycle
Pharmacokinetics and Pharmacodynamics
Time frame: At baseline and steady state during cycle 1
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Kyowa Kirin Co., Ltd.