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New treatment option for Type 1 Diabetes (T1D)
Official title A Study of GNTI-122 in Adults Recently Diagnosed With T1D
ClinicalTrials.gov ID: NCT06919354
What this study is testing
What is GNTI-122?
GNTI-122 is an investigational medicine, being studied as a potential treatment for type 1 diabetes (t1d).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- Male and female participants aged ≥18 to ≤55 years with recently diagnosed (within 180 days of Screening) T1D according to American Diabetes...
- 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.
You likely can't join 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.
See the full eligibility 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. 8\. Female participants of childbearing potential must have a negative serum pregnancy test at Screening, must be not lactating, and...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; San Diego, California, United States; San Francisco, California, United States; Gainesville, Florida, United States; Miami, Florida, United States; Boston, Massachusetts, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.