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Cell Therapy
Regulatory T Cells for ALS (REGALS Trial)
Phase 1
Recruiting
Led By Neil Shneider, MD, PhD
Research Sponsored by Cellenkos, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult ALS subjects (≥18 years of age)
Diagnosis of ALS, according to the Revised El Escorial Criteria for ALS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each measured at baseline and at weeks 5, 8, 12 and/or 13, 16, 20, 24 and/or 25, 36 and 48 from first infusion and/or at eot12 months
Awards & highlights
REGALS Trial Summary
This trial tests a potential new treatment for ALS using cells from umbilical cord blood to see if it is safe and effective.
Who is the study for?
This trial is for adults diagnosed with ALS within the last 5 years, who meet specific criteria (Revised El Escorial Criteria). They must not be on certain medications or have participated in other trials recently. Stable doses of Riluzole, Edaravone, or Albrioza are required if used. Participants need to agree to contraception during and after the study.Check my eligibility
What is being tested?
The trial tests CK0803 cells derived from umbilical cord blood as a treatment for ALS. It starts with a safety phase for 6 patients followed by a larger double-blind phase where participants randomly receive either CK0803 or an inactive substance without knowing which one they get.See study design
What are the potential side effects?
As this is an early-phase trial primarily assessing safety, potential side effects are being investigated but may include immune reactions due to cell transplantation and typical risks associated with infusion procedures.
REGALS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years or older with ALS.
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I have been diagnosed with ALS.
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My lung function, based on my age, sex, and height, is at least half of what is expected.
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My condition started less than 5 years ago.
REGALS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ each measured at baseline and at weeks 5, 8, 12 and/or 13, 16, 20, 24 and/or 25, 36 and 48 from first infusion and/or at eot12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each measured at baseline and at weeks 5, 8, 12 and/or 13, 16, 20, 24 and/or 25, 36 and 48 from first infusion and/or at eot12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Combined assessment of function and survival (CAFS)
Treatment Limiting Toxicity (TLT)
Secondary outcome measures
ALS Functional Rating Scale-Revised (ALSFRS-R) Score
Amyotrophic Lateral Sclerosis Specific Quality of Life - Revised (ALSSQOL-R)
Handheld dynamometer (HHD)
+6 moreREGALS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CK0803Experimental Treatment1 Intervention
CK0803 (cryopreserved, allogeneic, cord blood derived T regulatory cells that express neurotropic homing markers) will be administered intravenously Dose: 100 million Treg cells (fixed dose)
Dose regimen:
Induction: one infusion every 7 days (+/-3) x 4 doses
Consolidation: one infusion every 28 days (+/-3) x 5 doses
Group II: PlaceboPlacebo Group1 Intervention
Excipient
Find a Location
Who is running the clinical trial?
Cellenkos, Inc.Lead Sponsor
4 Previous Clinical Trials
87 Total Patients Enrolled
Arthur Slutsky, MD MASc BAScStudy DirectorUniversity of Toronto
Neil Shneider, MD, PhDPrincipal InvestigatorColumbia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a score between 36 and 45 on a test called ALSFRSR at the beginning of the study.I am 18 years or older with ALS.I am not pregnant or breastfeeding.I have been diagnosed with ALS.My lung function, based on my age, sex, and height, is at least half of what is expected.You have a very low platelet count or other abnormal blood test results that make you unsuitable for the study.I am willing to follow all study procedures and cooperate with the research team.I have been on a stable dose of Riluzole, Edaravone, or Albrioza for at least 30 days.You have an infection that hasn't gotten better after seven days of treatment with the right antibiotics. The Protocol medical monitor will make the final decision about whether you can join the study.I have not taken any blood thinners, including low-dose aspirin, in the last 14 days.I haven't taken any experimental drugs or treatments recently.Your blood tests for clotting should be normal.My condition started less than 5 years ago.I haven't had cancer treatment in the last 5 years, except for cervical or skin cancer.
Research Study Groups:
This trial has the following groups:- Group 1: CK0803
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Amyotrophic Lateral Sclerosis Patient Testimony for trial: Trial Name: NCT05695521 — Phase 1
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