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RECRUITINGPhase 1INTERVENTIONAL

A Study of GNTI-122 in Adults Recently Diagnosed With T1D

POLARIS: A Phase 1, Single Dose, Open-label Study of GNTI-122 in Adults With Recently Diagnosed Type 1 Diabetes (T1D)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a 78-week single arm, multi-center, Phase 1 study to evaluate the safety, tolerability, cellular kinetics, and biomarker changes in C-peptide over time of GNTI-122, an investigational cell therapy manufactured from a participant's own blood cells in adult participants with recently diagnosed T1D. After assessment of eligibility, participants who qualify for the study will be enrolled sequentially in 1 of 3 cohorts. Cohort 1 participants (n=3) receive a low dose of GNTI-122 . Cohort 2 participants (n=3) receive a high dose of GNTI-122. Cohort 3 participants (n=10) receive a high dose of GNTI-122 in combination with rapamycin. Participants are followed for 78 weeks after the administration of GNTI-122 during which safety and efficacy assessments are made, including vital signs, ECG, physical exam, clinical labs, and monitoring of adverse events and concomitant medications. Disease markers (e.g., MMTT-stimulated C-peptide, HbA1c) and pharmacodynamic activity (e.g., lymphocyte subsets and phenotypes, effector T cell responses to islet antigens ex vivo, T1D autoantibodies) will be monitored serially throughout the study. The study will include sentinel dosing and a Safety Review Committee to ensure participant safety. Visit https://www.polarisstudy.com to learn more!

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male and female participants aged ≥18 to ≤45 years with recently diagnosed (within 120 days of Screening) T1D according to American Diabetes Association criteria. 2. Participant has residual β-cell function during Screening, defined as random C-peptide ≥ 0.2 nmol/L. 3. Positive for at least one T1D-associated autoantibody. 4. Able and willing to provide written, willing to sign a consent form as approved by the IRB. 5. Is confirmed positive for the HLA-DRB1\*04:01 allele. 6. Has adequate vascular access to undergo leukapheresis with no known contraindications. 8\. Female participants of childbearing potential must have a negative serum pregnancy test at Screening, must be not lactating, and must agree to protocol-specified contraception. 9\. Male participants of childbearing potential must agree to protocol specified contraception. 10\. Other than T1D, participant is in good general health. Who Should NOT Join This Trial: 1. Type 2 diabetes. 2. Experienced DKA within 4 weeks prior to or during Screening. 3. Unwilling or unable to comply with study procedures or schedule. 4. Chronic or uncontrolled medical condition. 5. Has another active or autoimmune or inflammatory disease with the exception of well-controlled Hashimoto's thyroiditis, celiac disease, or vitiligo. 6. Participation in another clinical study or active follow-up in a prior study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Male and female participants aged ≥18 to ≤45 years with recently diagnosed (within 120 days of Screening) T1D according to American Diabetes Association criteria. 2. Participant has residual β-cell function during Screening, defined as random C-peptide ≥ 0.2 nmol/L. 3. Positive for at least one T1D-associated autoantibody. 4. Able and willing to provide written, informed consent as approved by the IRB. 5. Is confirmed positive for the HLA-DRB1\*04:01 allele. 6. Has adequate vascular access to undergo leukapheresis with no known contraindications. 8\. Female participants of childbearing potential must have a negative serum pregnancy test at Screening, must be not lactating, and must agree to protocol-specified contraception. 9\. Male participants of childbearing potential must agree to protocol specified contraception. 10\. Other than T1D, participant is in good general health. Exclusion Criteria: 1. Type 2 diabetes. 2. Experienced DKA within 4 weeks prior to or during Screening. 3. Unwilling or unable to comply with study procedures or schedule. 4. Chronic or uncontrolled medical condition. 5. Has another active or autoimmune or inflammatory disease with the exception of well-controlled Hashimoto's thyroiditis, celiac disease, or vitiligo. 6. Participation in another clinical study or active follow-up in a prior study.

Treatments Being Tested

BIOLOGICAL

GNTI-122

GNTI-122 is an investigational cell therapy manufactured from a participant's own blood cells and is intended to help correct an imbalance of certain types of cells found in participants with Type 1 Diabetes.

Locations (10)

City of Hope Medical Center
Duarte, California, United States
University of California - San Diego
San Diego, California, United States
University of California - San Francisco
San Francisco, California, United States
University of Florida - Gainesville
Gainesville, Florida, United States
University of Miami, Diabetes Research Institute
Miami, Florida, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States