Phase Ib, Open-label Study of Add on Therapy With CK0804 in Participants With Myelofibrosis, With Suboptimal Response to Ruxolitinib

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

To assess the safety and tolerability of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Ability to comprehend and willingness to sign a written informed consent form (ICF) for the study.

• Age above 18 years inclusive at the time of signing the ICF.

• Participants who fulfill the diagnostic criteria of myelofibrosis including primary myelofibrosis and myelofibrosis arising from polycythemia vera and essential thrombocythemia

• Life expectancy is greater than 6 months.

• 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: receiving ruxolitinib \>3 months prior to enrollment; AND stable dose for 8 weeks before starting therapy with CK0804

• Subject with evidence of evaluable residual burden of disease following ruxolitinib monotherapy treatment, consisting of:

‣ presence of grade ≥2 anemia or thrombocytopenia or neutropenia, OR

⁃ presence of disease-related symptoms, as determined by a Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN SAF TSS) score of ≥10 points, OR

⁃ documented splenomegaly of at least 5 cm below the costal margin as measured by physical examination or splenomegaly as documented by ultrasound or MRI.

• Willingness to avoid pregnancy or fathering children based on the criteria below

‣ Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 90 days after the last study treatment dose and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing should be communicated to the participants and their understanding confirmed.

⁃ Women of childbearing potential must have a negative serum pregnancy test at screening before the first dose (within 3 days of the first study treatment dose) and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through the safety follow-up visit and must not donate oocytes during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed,

⁃ Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) are eligible.

• ECOG performance status of 0 to 2

Locations
United States
California
UC Davis Health
RECRUITING
Sacramento
New York
Columbia University
NOT_YET_RECRUITING
New York
Montefiore Einstein Cancer Center
RECRUITING
The Bronx
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Tara Sadeghi
tara.sadeghi@cellenkosinc.com
713-806-4787
Backup
Stacy Minor
stacy.minor@cellenkosinc.com
832-962-7628
Time Frame
Start Date: 2022-12-27
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 24
Treatments
Experimental: Arm 1
CK0804 will be administered intravenously (IV) 100 million Treg Cells every 28 days up to 6 infusions.
Related Therapeutic Areas
Sponsors
Leads: Cellenkos, Inc.

This content was sourced from clinicaltrials.gov