Phase Ib, Open-label Study of Add on Therapy With CK0804 in Participants With Myelofibrosis, With Suboptimal Response to Ruxolitinib
Cellenkos, Inc.
Summary
To assess the safety and tolerability of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Ability to comprehend and willingness to sign a written informed consent form (ICF) for the study. 2. Age above 18 years inclusive at the time of signing the ICF. 3. Participants who fulfill the diagnostic criteria of myelofibrosis including primary myelofibrosis and myelofibrosis arising from polycythemia vera and essential thrombocythemia 4. Life expectancy is greater than 6 months. 5. Subject has been receiving ruxolitinib therapy, is unlikely to benefit from further ruxolitinib monotherapy in the opinion of the investigator; AND meeting the following criteria: recei…
Interventions
- DrugCK0804
CK0804 is a cryopreserved, allogeneic T-regulatory cell product that is manipulated to traffic to the bone marrow.
Locations (4)
- UC Davis HealthSacramento, California
- Columbia UniversityNew York, New York
- Montefiore Einstein Cancer CenterThe Bronx, New York
- The University of Texas MD Anderson Cancer CenterHouston, Texas