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

NCT06919354 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: GNTI-122-T1D-1001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 10

Brief Summary

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!

Conditions

Type 1 Diabetes Mellitus; Type 1 Diabetes (T1D)

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D

  Cumulative AEs/SAEs and clinically significant abnormalities in physical exams, vital signs, clinical laboratory measures, and other clinical assessments

  Week 78

Secondary Outcomes (3)

• Cellular kinetics of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D

  Week 78

• Cellular kinetics of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D

  Week 78

• Cellular kinetics of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D

  Week 78

Study Arms (1)

GNTI-122

EXPERIMENTAL

Biological: GNTI-122

Interventions

GNTI-122 BIOLOGICAL

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.

GNTI-122

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GentiBio, Inc: lead

Study Sites (10)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

University of California - San Diego

San Diego, California, 92093-0990, United States

RECRUITING

University of California - San Francisco

San Francisco, California, 94158, United States

RECRUITING

University of Florida - Gainesville

Gainesville, Florida, 32610, United States

RECRUITING

University of Miami, Diabetes Research Institute

Miami, Florida, 33136, United States

RECRUITING

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

NOT YET RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Related Links

• For more information, see our POLARIS study website

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mark Bach, MD

  GentiBio, Inc

  STUDY DIRECTOR

Central Study Contacts

Kristin M Neff

CONTACT

857-327-5483; clinical_ops@GentiBio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 9, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (10)