Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02691247 |
Recruitment Status :
Completed
First Posted : February 25, 2016
Results First Posted : January 8, 2021
Last Update Posted : January 8, 2021
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus | Biological: CLBS03 Low Dose Biological: CLBS03 High Dose Biological: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 113 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | February 2016 |
Actual Primary Completion Date : | March 2019 |
Actual Study Completion Date : | January 2020 |

Arm | Intervention/treatment |
---|---|
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.
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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.
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Biological: CLBS03 High Dose |
Placebo Comparator: Placebo
A single infusion of placebo, consisting of the infusion solution only
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Biological: Placebo |
- Change From Baseline in 4-hour Mixed Meal Tolerance Test (MMTT)-Stimulated C-peptide Area Under the Curve (AUC) at Week 52 [ Time Frame: Week 52 ]The area-under-curve of sequential C-peptide concentrations (AUC-Cpep) during the mixed-meal tolerance test (MMTT) is the gold-standard method to assess residual beta-cell (ie, insulin) secretion in type 1 diabetes.
- Change From Baseline in 4-hour Mixed Meal Tolerance Test (MMTT)-Stimulated C-peptide Area Under the Curve (AUC) at Week 104 [ Time Frame: Week 104 ]The area-under-curve of sequential C-peptide concentrations (AUC-Cpep) during the mixed-meal tolerance test (MMTT) is the gold-standard method to assess residual beta-cell (ie, insulin) secretion in type 1 diabetes.
- Change in Hemoglobin A1c (HbA1c) [ Time Frame: Week 104 ]
- Change From Baseline in Mean Daily Dose of Insulin [ Time Frame: Week 104 ]

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Ages Eligible for Study: | 8 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691247
United States, California | |
Rady Children's Hospital | |
San Diego, California, United States, 92123 | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Colorado | |
Barbara Davis Center for Diabetes | |
Aurora, Colorado, United States, 80045 | |
United States, Connecticut | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06519 | |
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States, 32610 | |
University of Miami, Diabetes Research Institute | |
Miami, Florida, United States, 33136 | |
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202 | |
United States, Massachusetts | |
Joslin Diabetes Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Missouri | |
Children's Mercy Kansas City | |
Kansas City, Missouri, United States, 64108 | |
United States, North Dakota | |
Sanford Research | |
Fargo, North Dakota, United States, 58122 | |
United States, Oregon | |
Oregon Health Science University | |
Portland, Oregon, United States, 97239 | |
United States, South Dakota | |
Sanford Research | |
Sioux Falls, South Dakota, United States, 57104 | |
United States, Tennessee | |
Vanderbilt Eskind Diabetes Clinic | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
Baylor College of Medicine / Texas Children's Hospital | |
Houston, Texas, United States, 77030 |
Study Director: | Douglas Losordo, MD | Caladrius Biosciences |
Documents provided by Caladrius Biosciences, Inc.:
Responsible Party: | Caladrius Biosciences, Inc. |
ClinicalTrials.gov Identifier: | NCT02691247 |
Other Study ID Numbers: |
CLBS03-P01 |
First Posted: | February 25, 2016 Key Record Dates |
Results First Posted: | January 8, 2021 |
Last Update Posted: | January 8, 2021 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
T1DM Type 1 Diabetes Mellitus T regulatory cell |
Immunotherapy Cell therapy T-Reg |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |