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CK0804 for Myelofibrosis (TREG108 Trial)

Phase 1
Recruiting
Research Sponsored by Cellenkos, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject with evidence of evaluable residual burden of disease following ruxolitinib monotherapy treatment
Age above 18 years inclusive at the time of signing the ICF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

TREG108 Trial Summary

This trial tests a new drug, CK0804, as a possible treatment for myelofibrosis. The trial will assess how safe and tolerable the drug is for people who have not responded well to another drug, ruxolitinib.

Who is the study for?
Adults over 18 with myelofibrosis not responding well to ruxolitinib can join this trial. They should have a life expectancy over 6 months, some remaining disease symptoms or spleen enlargement, and be able to follow the study plan. Women must test negative for pregnancy and avoid becoming pregnant; men must prevent fathering children during the study.Check my eligibility
What is being tested?
The trial is testing CK0804 as an additional treatment for those with myelofibrosis who haven't had enough improvement from ruxolitinib alone. The goal is to see if it's safe and how well patients tolerate it when added to their current therapy.See study design
What are the potential side effects?
Specific side effects of CK0804 aren't listed here, but generally, add-on therapies like this could cause immune reactions, fatigue, blood count changes or increase infection risk. Participants will be closely monitored for any adverse effects throughout the trial.

TREG108 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I still have signs of my disease after treatment with ruxolitinib alone.
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I am over 18 years old.
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I can take care of myself and am up and about more than half of my waking hours.
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I have been diagnosed with myelofibrosis, either primary or from polycythemia vera or essential thrombocythemia.

TREG108 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine Treatment limiting toxicity (TLT) as defined below
Secondary outcome measures
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.
Myeloproliferative disease
Rate of anemia response as per modified IWG-MRT ELN response criteria.
+1 more

TREG108 Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
CK0804 will be administered intravenously (IV) 100 million Treg Cells every 28 days up to 6 infusions.

Find a Location

Who is running the clinical trial?

Cellenkos, Inc.Lead Sponsor
4 Previous Clinical Trials
129 Total Patients Enrolled

Media Library

CK0804 Clinical Trial Eligibility Overview. Trial Name: NCT05423691 — Phase 1
Myelofibrosis Research Study Groups: Arm 1
Myelofibrosis Clinical Trial 2023: CK0804 Highlights & Side Effects. Trial Name: NCT05423691 — Phase 1
CK0804 2023 Treatment Timeline for Medical Study. Trial Name: NCT05423691 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared CK0804 for market release?

"CK0804 has limited clinical data supporting its efficacy and safety, so it was given a score of 1."

Answered by AI

Are there any available slots to join this clinical experiment?

"Clinical trials.gov confirms that, while the initial posting of this trial was on August 3rd 2022 and had its most recent alteration on June 28th 2022, recruitment for patients is not occurring at present. Nonetheless, 109 other studies are actively looking for participants right now."

Answered by AI
~1 spots leftby Apr 2024