Spots Global Cancer Trial Database for Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs
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Trial Identification
Brief Title: Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs
Official Title: Phase Ib, Open-label Study of Add on Therapy With CK0804 in Participants With Myelofibrosis, With Suboptimal Response to Ruxolitinib
Study ID: NCT05423691
Conditions
Interventions
Study Description
Brief Summary: To assess the safety and tolerability of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib
Detailed Description: 1. Safety Run-in The study will employ a 3+3+3 design to assess the safety and tolerability of the treatment based on treatment-limiting toxicities (TLTs) occurring up to 1 Cycle (28 days) after the first infusion. 2. Expansion After a total of 9 participants completed 28 days and are evaluated for tolerability in the safety run-in phase, additional participants may be included in the expansion cohort in order to have approximately 24 evaluable myelofibrosis
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UC Davis Health, Sacramento, California, United States
Montefiore Einstein Cancer Center, Bronx, New York, United States
Columbia University, New York, New York, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
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