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RecruitingPhase 1

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Heart tracing (ECG), Physical exams

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Safety and tolerability assessments over the 78-week study include: vital signs, 12-lead electrocardiograms, physical examinations, clinical laboratory evaluations, monitoring of adverse events and concomitant medications."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests GNTI-122, an experimental cell treatment made from a person's own blood cells, in adults recently diagnosed with type 1 diabetes (T1D). It checks safety and changes in signs of diabetes over 78 weeks after treatment. Some participants also receive a drug called rapamycin.

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!

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 55 years old and were diagnosed with T1D within 180 days before screening.
  • Still make some insulin, shown by a C-peptide blood test result of at least 0.2 nmol/L.
  • Have at least one T1D-related autoantibody, a protein from the immune system that targets the body's own cells.
  • Have the gene version called HLA-DRB1*04:01.
  • Can and will give written consent to join the study.
  • Have veins suitable for leukapheresis, a procedure that collects white blood cells, and no known reason it would be unsafe.
  • If able to have children, agree to the study's birth control rules. Women who could become pregnant must also have a negative blood pregnancy test at screening and not be breastfeeding.
  • Are in good general health apart from T1D.

Who can't join

  • Have type 2 diabetes.
  • Had diabetic ketoacidosis (DKA), a dangerous buildup of acids in the blood, within 4 weeks before screening or during screening.
  • Cannot or will not follow the study procedures or schedule.
  • Have a long-term or uncontrolled medical condition.
  • Have another active disease, autoimmune disease (when the immune system attacks the body), or disease that causes inflammation. Well-controlled Hashimoto's thyroiditis, celiac disease, or vitiligo are allowed exceptions.
  • Are in another clinical study or still having active follow-up visits for a past study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Male and female participants aged ≥18 to ≤55 years with recently diagnosed (within 180 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.

Study sites (10)

CA

FL

MA

NC

NY