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

Launched by GENTIBIO, INC · Apr 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GNTI-122 for adults who have recently been diagnosed with Type 1 Diabetes (T1D). The goal is to see if this treatment is safe and how it affects certain markers in the body, particularly C-peptide, which can indicate how well the body is producing insulin. Participants will be divided into three groups: one will receive a low dose of the treatment, another a high dose, and the third group will receive the high dose along with another medication called rapamycin. The study will last for 78 weeks, during which participants will have regular check-ups to monitor their health and the treatment's effects.

To be eligible for this trial, participants must be between 18 and 45 years old, have been diagnosed with T1D within the last 120 days, and still have some remaining insulin-producing cell function. They must also be on insulin therapy and meet certain health criteria. Throughout the study, participants will be closely monitored for safety, and there will be a special review committee to ensure their well-being. The trial is not yet recruiting, but it aims to help improve future treatments for those living with T1D.

Gender

ALL

Eligibility criteria

• 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. Requires and is on insulin therapy.
• • 6. Is confirmed positive for the HLA-DRB1\*04:01 allele.
• • 7. 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.