GNTI-122 for Type 1 Diabetes

(POLARIS Trial)

Recruiting at 7 trial locations

Overseen By Kristin M Neff

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: GentiBio, Inc

Must be taking: Insulin

Disqualifiers: Type 2 diabetes, DKA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

16 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, since participants must be on insulin therapy, you will likely continue with that medication.

What is the purpose of this trial?

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.

Research Team

Mark Bach, MD

Principal Investigator

GentiBio, Inc

Eligibility Criteria

Adults recently diagnosed with Type 1 Diabetes (T1D) are eligible for this trial. It's important that they meet certain health standards to be included, but specific inclusion criteria aren't listed here. Those who have other medical conditions or circumstances that could interfere with the study may not qualify.

Inclusion Criteria

Able and willing to provide written, informed consent as approved by the IRB

I am currently using insulin for my diabetes.

I have antibodies linked to type 1 diabetes.

Exclusion Criteria

I don't have active autoimmune diseases except for controlled Hashimoto's, celiac, or vitiligo.

Chronic or uncontrolled medical condition

Participation in another clinical study or active follow-up in a prior study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of GNTI-122, with Cohort 3 also receiving rapamycin

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and efficacy, including vital signs, ECG, and clinical labs

78 weeks

Regular visits (in-person and virtual)

Long-term follow-up

Participants are monitored for specific toxicities for a total of 15 years

15 years

Semi-annually or annually

Treatment Details

Interventions

• GNTI-122

Trial Overview The trial is testing GNTI-122, a cell therapy made from participants' own blood cells. There are three groups: one gets a low dose, another a high dose, and the third receives a high dose combined with rapamycin. Participants will be monitored over 78 weeks for safety and how well the treatment works.

Participant Groups

Group I: GNTI-122 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

GentiBio, Inc

Lead Sponsor

Trials

1

Recruited

50+