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Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)

This study is currently recruiting participants.
Verified September 2017 by Caladrius Biosciences, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02691247
First Posted: February 25, 2016
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Sanford Health
Information provided by (Responsible Party):
Caladrius Biosciences, Inc.
February 12, 2016
February 25, 2016
September 19, 2017
February 2016
March 2019   (Final data collection date for primary outcome measure)
Mixed Meal Tolerance Test (MMTT)-stimulated C-peptide area under the curve (AUC) [ Time Frame: Week 52 ]
Same as current
Complete list of historical versions of study NCT02691247 on ClinicalTrials.gov Archive Site
  • MMTT-stimulated C-peptide AUC [ Time Frame: Week 104 ]
  • Change in hemoglobin A1c (HbA1c) [ Time Frame: Week 104 ]
  • Change in insulin usage [ Time Frame: Week 104 ]
  • Proportion of subjects with adverse events [ Time Frame: Week 104 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)
A Prospective Randomized Placebo-Controlled Double Blind Clinical Trial to Evaluate the Safety and Efficacy of CLBS03 (Autologous Ex Vivo Expanded Polyclonal Regulatory T-cells) in Adolescents With Recent Onset Type 1 Diabetes Mellitus (T1DM)
This clinical trial will explore the safety and effect of autologous ex vivo expanded polyclonal regulatory T-cells on beta cell function in patients, aged 8 to 17, with recent onset T1DM. Other measures of diabetes severity and the autoimmune response underlying T1DM will also be explored. Eligible subjects will receive a single infusion of CLBS03 (high or low dose) or placebo.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus
  • Biological: CLBS03 Low Dose
  • Biological: CLBS03 High Dose
  • Biological: Placebo
  • Experimental: CLBS03 Low Dose
    A single infusion of CLBS03 Low Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP (United States Pharmacopoeia) infusion solution.
    Intervention: Biological: CLBS03 Low Dose
  • Experimental: CLBS03 High Dose
    A single infusion of CLBS03 High Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP infusion solution.
    Intervention: Biological: CLBS03 High Dose
  • Placebo Comparator: Placebo
    A single infusion of placebo, consisting of the infusion solution only
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
111
March 2020
March 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and females aged 8 to 17 years of age
  • Diagnosis of T1DM within 100 days of receipt of study drug
  • Positive for at least one islet cell autoantibody
  • Peak MMTT-stimulated C-peptide level > 0.2 pmol/mL (at the screening visit)
  • Weight of ≥30 kg
  • Must agree to use a reliable and acceptable method of contraception for the duration of participation
  • Willing and medically acceptable to postpone live vaccine immunizations for one year after infusion
  • Written informed consent and written assent

Exclusion Criteria:

  • Hemoglobin less than the lower limit of normal
  • Leukocytes <3,000/μL; neutrophils <1,500/μL; lymphocytes <800/μL; platelets <100,000/μL
  • Regulatory T-cells present in peripheral blood at <20 cells per μL
  • Current or ongoing use of non-insulin pharmaceuticals (that may affect glycemic control)
  • Current or anticipated use of systemic corticosteroids or other immunomodulatory drugs
  • Recent serious bacterial, viral, fungal, or other opportunistic infections
  • History of malignancy or serious uncontrolled cardiovascular, nervous system, pulmonary, renal, or gastrointestinal disease
  • Serologic evidence of current or past viral infection: human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C, and human T-lymphotropic virus (HTLV) 1/2
  • Positive QuantiFERON® tuberculosis (TB) test, purified protein derivative (PPD) skin test, history of tuberculosis, or active TB infection
  • Active infection with Epstein-Barr Virus or Cytomegalovirus
  • Liver disease
  • Pregnant or breast-feeding
  • Vaccination with a live virus within 8 weeks of receipt of study drug
  • Vaccination with a killed virus within 2 weeks of receipt of study drug
  • Participation in an investigational drug study within 90 days prior to screening
  • Previously treated with a T-Reg based cell therapy
  • History of allergy to gentamicin
Sexes Eligible for Study: All
8 Years to 17 Years   (Child)
No
Contact: Christine Kotynski ckotynski@caladrius.com
Contact: Scott Volk svolk@caladrius.com
United States
 
 
NCT02691247
CLBS03-P01
Yes
Not Provided
Plan to Share IPD: No
Caladrius Biosciences, Inc.
Caladrius Biosciences, Inc.
Sanford Health
Study Director: Douglas Losordo, MD Caladrius Biosciences
Caladrius Biosciences, Inc.
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP