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

GentiBio, Inc · with California Institute for Regenerative Medicine (CIRM) · NCT06919354

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–55 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
16
US sites recruiting
9
Study start
September 3, 2025
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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!

Being studied: GNTI-122

Conditions: Type 1 Diabetes (T1D); Type 1 Diabetes Mellitus

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Male and female participants aged ≥18 to ≤55 years with recently diagnosed (within 180 days of Screening) T1D according to American Diabetes Association criteria.
  • Participant has residual β-cell function during Screening, defined as random C-peptide ≥ 0.2 nmol/L.
  • Positive for at least one T1D-associated autoantibody.
  • Able and willing to provide written, informed consent as approved by the IRB.
  • Is confirmed positive for the HLA-DRB1*04:01 allele.
  • Has adequate vascular access to undergo leukapheresis with no known contraindications.
  • 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.
  • Male participants of childbearing potential must agree to protocol specified contraception.
  • Other than T1D, participant is in good general health.

Exclusion Criteria

  • Type 2 diabetes.
  • Experienced DKA within 4 weeks prior to or during Screening.
  • Unwilling or unable to comply with study procedures or schedule.
  • Chronic or uncontrolled medical condition.
  • Has another active or autoimmune or inflammatory disease with the exception of well-controlled Hashimoto's thyroiditis, celiac disease, or vitiligo.
  • Participation in another clinical study or active follow-up in a prior study.

Recruiting US locations

  • City of Hope Medical Center

    Duarte, CA 91010

    Site contact: Fouad Kandeel, MD, PhD · 866-444-7538 · islets@coh.org

  • University of California - San Diego

    San Diego, CA 92093-0990

    Site contact: Mateo Santizo · 858-249-4020 · alphastemcellclinic@health.ucsd.edu

  • University of California - San Francisco

    San Francisco, CA 94158

    Site contact: Rebecca Wesch (Recruitment Coordinator) · 844-813-8273 · clinicalresearch@diabetes.ucsf.edu

  • University of Florida - Gainesville

    Gainesville, FL 32610

    Site contact: Jennifer Hosford · 352-294-5759 · jennifer.hosford@peds.ufl.edu

  • University of Miami, Diabetes Research Institute

    Miami, FL 33136

    Site contact: Carlos Blaschke, MD · 305-243-4485 · cblaschke@miami.edu

  • Joslin Diabetes Center

    Boston, MA 02215

    Site contact: Michelle Zhang, Study Coordinator · 888-813-8669 · T1DTrials@joslin.harvard.edu

  • Icahn School of Medicine at Mount Sinai

    New York, NY 10029

    Site contact: Camilla Levister, NP · 212-241-5177 · Camilla.levister@mssm.edu

  • University of North Carolina at Chapel Hill

    Chapel Hill, NC 27514

    Site contact: Rachael Unger · 984-974-3004 · uncdiabetes@med.unc.edu

  • Duke University

    Durham, NC 27710

    Site contact: Megan Reaves · 919-660-2272 · megan.reaves@duke.edu

Study contacts (from the official record)

  • Kristin M Neff · 857-327-5483 · clinical_ops@GentiBio.com
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A Study of GNTI-122 in Adults Recently Diagnosed With T1D (NCT06919354) | Bored Studies