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Phase 1 Safety Run-in Study and Phase 1b Randomized, Double Blinded, Placebo Controlled Trial

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Trial Profile

Phase 1 Safety Run-in Study and Phase 1b Randomized, Double Blinded, Placebo Controlled Trial

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 22 Feb 2024

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At a glance

  • Drugs CK 0803 (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms REGALS
  • Sponsors Cellenkos

    • Most Recent Events

    • 19 Feb 2024 According to a Cellenkos media release, the company got approval from the Data Safety Monitoring Board (DSMB) for CK0803 neurotrophic T regulatory (Treg) cell therapy,to proceed with the second group of patients in the trial
    • 19 Jan 2024 According to a Cellenkos media release, Dr. James Orengo is principal investigator of this study.
    • 19 Jan 2024 According to a Cellenkos media release, the first cohort of phase 1/1b CK0803 trial has been completed and is currently open for enrollment at Columbia University, New York, NY, led by PI, Dr Neil Shneider, M.D., Ph.D., director of Columbia Universitys Eleanor and Lou Gehrig ALS Center.

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