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

ID#: NCT06919354

Age: 18 - 45 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: September 03, 2025

End Date: February 01, 2028

Contact Information:
Kristin M Neff
857-327-5483
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.
Eligibility:

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.
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