A T cell phenotype signature driven dose finding study with siplizumab in type 1 diabetes mellitus

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Open label study in subjects age 8-45 with T1D diagnosis within 18 months to identify a safe and metabolically favorable dosing regimen of siplizumab.


Child to Adult


Ages 8-45 Diagnosed with T1D within 18 months of enrollment Received primary COVID-19 vaccination series and any additional vaccine doses for which the participant qualifies according to current CDC recommendations. Have not used other investigational drugs within 24 weeks of participation Does not have a history of severe reaction to humanized monoclonal antibodies

Inclusion: -8 to 45 years of age. -Diagnosis of T1DM within 18 months (550 days) of enrollment (V0). -Positive for at least one diabetes-related autoantibody -Peak stimulated C-peptide level > 0.15 pmol/mL following a MMTT conducted -Completion of a primary SARS-CoV-2 vaccination series, including any additional vaccine dose(s) for which the participant qualifies for, according to current CDC recommendations and FDA approval(s) or emergency use authorization(s). If the participant requires administration of vaccine(s) to meet eligibility requirements, they must complete the vaccination series at least 2 weeks prior to enrollment (V0). Exclusion Criteria -Use of investigational drugs within 24 weeks of participation with the exception of any vaccine for the prevention of SARS-CoV-2 infection and emergency use authorization medications for treating SARS-CoV-2. -Severe reaction or anaphylaxis to humanized monoclonal antibodies. -History of significant allergy (e.g., anaphylaxis) to milk or soy proteins. -History of recent (within 180 days of V0) or ongoing uncontrolled bacterial, viral, fungal or other opportunistic infections, including: a. Human immunodeficiency virus (HIV), b. Current or prior infection with hepatitis B (HBV), as indicated by positive HBsAg or positive HBcAb, c. Current or prior hepatitis C (HCV), unless treated with anti-viral therapy with achievement of a sustained virologic response (undetectable viral load 12 weeks after cessation of therapy), d. Positive QuantiFERON-TB Gold or QuantiFERON-TB Gold Plus tests. PPD or T-SPOT?.TB may be substituted for the QuantiFERON-TB Gold or QuantiFERON-TB Gold Plus tests, e. Active infection with EBV as detected by PCR or serology at the screening visit (V-1), f. Active infection with cytomegalovirus (CMV) as detected by PCR or serology at the screening visit (V-1), -Positive molecular testing of SARS-CoV-2 within 30 days of V-1. -Any of the following laboratory abnormalities within 37 days of enrollment (V0), confirmed by repeat tests at least 1 week apart: a. White blood count (WBC) < 3 x 103/μL;, b. CD4+ count below the lower limit of normal, c. Platelet count < 150,000 /μL, d. Hemoglobin < 10 g/dL, e. ALT ≥ 2x upper limit of normal (ULN) or f. AST ≥ 2x ULN. -Prior or current treatment that is known to alter the natural history of T1DM or immunologic status, including high dose inhaled, extensive topical or systemic glucocorticoids. -Current or prior (within last 14 days of the V-1 MMTT) use of any medication known to influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, thiazide, or other potassium-depleting diuretics, β-adrenergic blockers, niacin). -Current or prior (within the last 30 days of the V-1 MMTT) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin. -Previous or current diagnosis of malignancy. -History of bone marrow transplantation, or autoimmune disease associated with lymphopenia. -History or diagnoses of other autoimmune diseases with the exception of stable thyroid or celiac disease. -History of significant cardiovascular disease. -Vaccination with a live attenuated vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette- Guerin, and smallpox) within 30 days of V0. -Women of child-bearing potential who are unwilling to use a medically acceptable form of contraception from 14 days prior to V0 until study Week 52. -Women who are pregnant, lactating, or planning on pregnancy during the study. -Current, diagnosed mental illness (e.g., severe depression), current diagnosed or self-reported drug, or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements

Type of Study



Barbara Davis Center
University of Colorado Hospital

Principal Investigator
Photograph of Peter Gottlieb,  MD

Peter Gottlieb, MD

Study ID

Protocol Number: 22-0999

More information available at ClinicalTrials.gov: NCT05574335

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