Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs (TREG108)
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|ClinicalTrials.gov Identifier: NCT05423691|
Recruitment Status : Not yet recruiting
First Posted : June 21, 2022
Last Update Posted : June 30, 2022
|Condition or disease||Intervention/treatment||Phase|
|Myelofibrosis||Drug: CK0804||Phase 1|
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.
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a single-arm study consisting of a safety run-in (3+3+3 design) followed by an expansion cohort after completion of safety run-in data is evaluated for tolerability in the safety.|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib, Open-label Study of Add on Therapy With CK0804 in Participants With Myelofibrosis, With Suboptimal Response to Ruxolitinib|
|Estimated Study Start Date :||August 3, 2022|
|Estimated Primary Completion Date :||October 30, 2023|
|Estimated Study Completion Date :||April 30, 2024|
Experimental: Arm 1
CK0804 will be administered intravenously (IV) 100 million Treg Cells every 28 days up to 6 infusions.
CK0804 is a cryopreserved, allogeneic T-regulatory cell product that is manipulated to traffic to the bone marrow.
- To determine Treatment limiting toxicity (TLT) as defined below [ Time Frame: 28 days ]
- severe (grade 3 or 4) infusion-related toxicity within 24 hours (NCI-CTCAE V5.0) of exposure that does not resolve with standard of care treatment within 72 hours.
- regimen related death within 28 days
- Assessment of overall response rate (ORR) (measured as CR or PR) and its duration, using modified International Working Group-Myeloproliferative Neoplasm Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) consensus report. [ Time Frame: 6 months ]To determine the efficacy of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib
- Rate of anemia response as per modified IWG-MRT ELN response criteria. [ Time Frame: 6 months ]To determine the efficacy of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib
- Rate of spleen response by imaging at and after 24 weeks as per IWG-MRT ELN response criteria [ Time Frame: 6 months ]To determine the efficacy of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib
- Percentage of Participants who will Achieve Total Symptom Score Reduction Greater Than or Equal to (≥) 50% (TSS50) as Measured by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05423691
|Contact: Tara Sadeghiemail@example.com|
|Contact: Stacy Minorfirstname.lastname@example.org|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Contact: Alleyne Genevieve 713-792-4986 GMAlleyne@mdanderson.org|
|Principal Investigator: Lucia Masarova, MD|