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TREG108NCT05423691

Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved 12 months later.

See at-risk trials from Cellenkos, Inc.

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Record History

All 8 versions: 8 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Apr 30, 2026 to Apr 30, 2027 Show 4 more changesShow less
    • Study completion pushed from Dec 30, 2026 to Dec 30, 2027
    • Publications: details revised at 33 of 34 entries
    • Eligibility criteria shortened, about 4 words
    • Study description expanded, about 2 words
  2. Primary completion date: Apr 30, 2024 to Apr 30, 2026
    • Study completion date: Apr 30, 2024 to Dec 30, 2026
    v7
  3. Site details revised at 2 of 4 sitesv6
  4. Primary completion date: Oct 30, 2023 to Apr 30, 2024
    • Study sites: 3 to 4
    v5
  5. Study sites: 1 to 3
    • Start date changed from estimate of Dec 16, 2022 to Dec 27, 2022
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 3, 2022 to Dec 16, 2022
    • Site details revised
    v3
  2. Study sites: 0 to 1v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

To determine Treatment limiting toxicity (TLT) as defined below
Timeframe: 28 days

Secondary (4)

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

Arms and interventions

Arm 1Experimental

CK0804 will be administered intravenously (IV) 100 million Treg Cells every 28 days up to 6 infusions.

Drugs: CK0804

Sites

4 sites in 1 country