T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs
Completed · Phase 1
Conditions studied: Type 1 Diabetes Mellitus
In brief
The investigational therapy under study in this trial, regulatory T cells (Tregs), offers the hope of stabilizing further destruction of insulin producing beta cells in type 1 diabetes. Tregs are a specialized subset of T cells that function to control the immune response. Pre-clinical studies in non-obese diabetic mice have demonstrated that adoptive transfer of Tregs can slow diabetes progression and, in some cases, reverse new onset diabetes. The primary purpose of this Phase 1 study is to assess the safety and feasibility of intravenous infusion of ex vivo selected and expanded autologous polyclonal Tregs in patients with type 1 diabetes (T1DM) to support dose selection for a future efficacy trial. The study also aims to assess the effect of Tregs on beta cell function as well as on other measures of diabetes severity and the autoimmune response underlying T1DM.
Key facts
- Study ID
- NCT01210664
- Run by
- University of California, San Francisco
- People needed
- 16
- Starts
- 2010-11-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2018-07-11
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of T1DM within >3 and <24 months of screening according to the American Diabetes Association criteria
- Between 18 and 45 years of age
- Positive test for Epstein-Barr antibody
- Positive test for at least one of the following antibodies:
- ICA512-antibody
- ICA
- GAD65-antibody
- Insulin (if assessed within 10 days of the onset of insulin therapy)
- ZnT8
- Peak C-peptide >0.1 pmol/ml (>0.3 ng/ml) during MMTT challenge
- Adequate venous access to support draw of 400 ml whole blood and infusion of investigational therapy
You may not qualify if…
- Hemoglobin <10.0 g/dL; leukocytes <3,000/µL; neutrophils <1,500/µL; lymphocytes <800/µL; platelets <100,000/µL
- Regulatory T cells present in peripheral blood at <10 per µl as determined by flow cytometry
- Serologic evidence of HIV-1 or HIV-2 infection
- Evidence of current hepatitis B as demonstrated by HBsAg or circulating hepatitis B genomes
- Serologic evidence of hepatitis C infection
- Detectable circulating EBV or CMV genomes or active infection
- Positive PPD skin test defined as greater than or equal to 10 mm induration
- Chronic use of systemic glucocorticoids or other immunosuppressive agents, or biologic immunomodulators within 6 months prior to study entry. Specifically, subjects who have received over 7 days of treatment with 7.5mg of prednisone (or the equivalent) within 6 months prior to study entry will be excluded.
- History of malignancy ( including squamous cell carcinoma of the skin or cervix) except adequately treated basal cell carcinoma
- Any chronic illness or prior treatment which in the opinion of the investigator should preclude participation in the trial
- Pregnant or breastfeeding women, any female who is unwilling to use a reliable and effective form of contraception for 2 years afer Treg dosing and any male who is unwilling to use a reliable and effective form of contraception for 3 months after Treg dosing.
Where it is running
- University of California, San Francisco Medical Center — San Francisco, California, United States
- Yale University — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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