Health TrialsbyHealthPanel

Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs

ConditionMyelofibrosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCellenkos, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Any major surgery within 28 days before the first dose of study treatment.

Undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation.

Received chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.

Participant has received splenic irradiation within the past 6 months.

Trial design

Design model

Single group

Treatments tested in this trial

  • CK0804

    Drug

    CK0804 is a cryopreserved, allogeneic T-regulatory cell product that is manipulated to traffic to the bone marrow.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Arm 1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To determine Treatment limiting toxicity (TLT) as defined below

* 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

Time frame
28 days

Secondary outcomes

1

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.

To determine the efficacy of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib

Time frame
6 months
2

Rate of anemia response as per modified IWG-MRT ELN response criteria.

To determine the efficacy of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib

Time frame
6 months
3

Rate of spleen response by imaging at and after 24 weeks as per IWG-MRT ELN response criteria

To determine the efficacy of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib

Time frame
6 months
4

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)

To determine the efficacy of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cellenkos, Inc.

Lead sponsor

Source ClinicalTrials.gov
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