Regulatory T Cells for Amyotrophic Lateral Sclerosis

Running, not enrolling · Phase 1 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

Phase 1 Safety Run-in Study of 6 patients followed by Phase 1b Randomized, Double Blind, Placebo Control Trial of CK0803, neurotropic, allogeneic, umbilical cord blood derived T regulatory (Treg) cells in additional 60 patients with Amyotrophic Lateral Sclerosis.

Key facts

Study ID

NCT05695521

Run by

Cellenkos, Inc.

People needed

66

Starts

2023-04-03

Expected to finish

2027-12-01

Last updated by the study team

2025-04-11

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability of the subject or his/her legally authorized representative to provide informed consent.
• Adult ALS subjects (≥18 years of age)
• Diagnosis of ALS, according to the Revised El Escorial Criteria for ALS
• Subjects with disease onset ≤ 5 years
• Upright (sitting position) Slow Vital Capacity (SVC) as adjusted for sex, age and height ≥ 50% predicted
• Subjects must have documented ALSFRSR score of 36-45 at baseline.
• Subjects taking concomitant Riluzole or Edaravone or Albrioza at study entry must be on a stable dose for ≥ 30 days prior to the first dose of study treatment (Day 1).
• Screening values of coagulation parameters including platelet count, international normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (APTT) should be within normal ranges.
• Agree to practice highly effective contraception during the study and continue contraception for 90 days after their last dose of study treatment.

You may not qualify if…

• Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol medical monitor is the final arbiter of eligibility.
• Antiplatelet or anticoagulant therapy within the 14 days prior to Day 1 or anticipated use during the study, including but not limited to daily aspirin including low dose aspirin (defined as ≤ 150 mg/day), clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban and apixaban
• Clinically significant low platelet count (defined as < 100,000/mm3), coagulation tests, or laboratory abnormalities that would render a subject unsuitable for inclusion
• Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator
• Have any other conditions, which, in the opinion of the Investigator would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study
• Concurrent participation in any other interventional clinical study
• Treatment with another investigational drug, biological agent, or device, including, but not limited to sodium phenylbutyrate, within 1 month of Screening, or 5 half-lives of investigational agent, whichever is longer
• Treatment of cancer in the last 5 years (except in situ carcinoma of the cervix or basal cell carcinoma)
• Female subjects who are pregnant or currently breastfeeding
• Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment.

Where it is running

• Columbia University Irving Medical Center — New York, New York, United States
• Baylor College of Medicine — Houston, Texas, United States
• Michael E. DeBakey Veterans Affairs Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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