Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05423691

Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs

Led by Cellenkos, Inc. · Updated on 2025-04-13

24

Participants Needed

4

Research Sites

209 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to sign informed consent
  • Age 18 years or older at consent
  • Diagnosed with myelofibrosis including primary, post-polycythemia vera, or post-essential thrombocythemia
  • Life expectancy greater than 6 months
  • Receiving ruxolitinib therapy for more than 3 months and stable dose for at least 8 weeks
  • Evidence of residual disease after ruxolitinib, including anemia, thrombocytopenia, neutropenia, symptoms scoring 10 points or more, or splenomegaly at least 5 cm below costal margin
  • Willing to avoid pregnancy or fathering children during the study and follow contraceptive guidelines
  • ECOG performance status 0 to 2
Not Eligible

You will not qualify if you...

  • Major surgery within 28 days before first study dose
  • Prior allogeneic or autologous stem cell transplant or candidate for transplant
  • Treatment with chemotherapy, immunomodulatory, immunosuppressive, biological, endocrine, targeted, antibody, or hypomethylating agents within 5 half-lives or 28 days before first dose, except ruxolitinib
  • Splenic irradiation within past 6 months
  • Significant uncontrolled medical condition or infection
  • Unable or unlikely to comply with study treatment or evaluations
  • Pregnant or breastfeeding women
  • Any condition interfering with full participation or posing risk
  • Laboratory values: platelets <50 x 10^9/L without assistance, ANC <0.5 x 10^9/L, ALT or AST ≥2.5 x ULN, direct bilirubin >2 x ULN, ALP ≥3 x ULN, creatinine clearance <50 mL/min
  • Unwillingness to receive blood transfusions
  • Unable or unwilling to sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

UC Davis Health

Sacramento, California, United States, 95817

Actively Recruiting

2

Columbia University

New York, New York, United States, 10032

Not Yet Recruiting

3

Montefiore Einstein Cancer Center

The Bronx, New York, United States, 10461

Actively Recruiting

4

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

T

Tara Sadeghi

CONTACT

S

Stacy Minor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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