Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs
Part of paid clinical trials in Sacramento, California.
- Sponsor
- Cellenkos, Inc.
- Study ID
- NCT05423691
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Myelofibrosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CK0804 — DRUGCK0804 is a cryopreserved, allogeneic T-regulatory cell product that is manipulated to traffic to the bone marrow.
Study Details
To assess the safety and tolerability of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib
Key Dates
- Start date
- Dec 27, 2022
- Status verified
- Apr 2025
- Primary completion
- Apr 30, 2026
- Completion
- Dec 30, 2026
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1CK0804 will be administered intravenously (IV) 100 million Treg Cells every 28 days up to 6 infusions.
Primary Outcome Measure
To determine Treatment limiting toxicity (TLT) as defined below [ Time Frame: 28 days ]
Central Contacts
- Tara Sadeghi713-806-4787
- Stacy Minor832-962-7628
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UC Davis Health | Sacramento | California | 95817 | Mehrdad Abedi, MD (PRINCIPAL_INVESTIGATOR) |
| Columbia University | New York | New York | 10032 | Mark Heaney, MD (PRINCIPAL_INVESTIGATOR) |
| Montefiore Einstein Cancer Center | The Bronx | New York | 10461 | Clinical Research Coordinator Swati Goel, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Lucia Masarova, MD (PRINCIPAL_INVESTIGATOR) |
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