Clinical Trial Details

NCT ID: NCT02691247
Date Last Changed: September 18, 2017

Overview

Research Study Summary

A Phase 2 clinical study for patients with Diabetes Mellitus (The Sanford Project T-Rex Study)

Research Study 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)

Purpose

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.

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
8 to 17 Years
Overall Status
Recruiting
Lead Sponsor
Caladrius Biosciences, Inc.
Duration
37 Months
Facility Type
N/A
Compensation

Eligibility

All ages 8 Years to 17 Years

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

Site Locations (15)

Country State City Zip Facility and Contact
United States California San Diego 92123 Rady Children's Hospital
Marla Hashiguchi, RN
858-966-8940
mhashiguchi@rchsd.org

Michael Gottschalk, MD, PhD
Principal Investigator
United States California San Francisco 94143 University of California, San Francisco
Christine Torok, RN
415-502-9089
christine.torok@ucsf.edu

Stephen E. Gitelman, MD
Principal Investigator
United States Colorado Aurora 80045 Barbara Davis Center for Diabetes
Ruthie Williamson
303-724-6894
Ruthie.Williamson@ucdenver.edu

Peter Gottlieb, MD
Principal Investigator
United States Connecticut New Haven 06519 Yale University School of Medicine
Naomi Yama, RN
203-737-2737
naomi.yama@yale.edu

Kevan C. Herold, MD
Principal Investigator
United States Florida Gainesville 32610 University of Florida
Miriam Cintron
352-273-5580
cintrm@peds.ufl.edu

Michael J. Haller, MD
Principal Investigator
United States Florida Miami 33136 University of Miami, Diabetes Research Institute
Della Matheson
305-243-3781
dmatheso@med.miami.edu

David A. Baidal, MD
Principal Investigator
United States Indiana Indianapolis 46202 Indiana University
Maureen Mullen
317-278-7036
maamulle@iu.edu

Linda DiMeglio, MD, MPH
Principal Investigator
United States Massachusetts Boston 02215 Joslin Diabetes Center
Brittany Resnick
888-813-8669
brittany.resnick@joslin.harvard.edu

Jason Gaglia, MD
Principal Investigator
United States Minnesota Minneapolis 55455 University of Minnesota
Beth Pappenfus
612-624-2922
papp0086@umn.edu

Antoinette Moran, MD
Principal Investigator
United States Missouri Kansas City 64108 Children's Mercy Kansas City
Anne Clark, RN
816-760-5592
akclark@cmh.edu

Mark A. Clements, MD
Principal Investigator
United States North Dakota Fargo 58122 Sanford Research
Sarah Jacobson, RN
701-234-6063
sarah.jacobson@sanfordhealth.org

Luis Casas, MD
Principal Investigator
United States Oregon Portland 97239 Oregon Health Science University
Rebecca Fitch
503-494-4739
fitch@ohsu.edu

Ines Guttmann-Bauman, MD
Principal Investigator
United States South Dakota Sioux Falls 57104 Sanford Research
Christina Huber
605-328-8741
christina.huber@sanfordhealth.org

Kurt Griffin, MD, PhD
Principal Investigator
United States Tennessee Nashville 37232 Vanderbilt Eskind Diabetes Clinic
Faith Brendle
615-875-6150
faith.brendle@vanderbilt.edu

Daniel Moore, MD
Principal Investigator
United States Texas Houston 77030 Baylor College of Medicine / Texas Children's Hospital
Christopher Williams
832-824-1580
cxwilli1@texaschildrens.org

Maria Jose Redondo, MD, PhD, MPH
Principal Investigator

Contact

Christine Kotynski

E-mail:

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