GNTI-122 for Type 1 Diabetes

(POLARIS Trial)

Recruiting at 10 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called GNTI-122 for individuals recently diagnosed with Type 1 Diabetes (T1D). The goal is to determine if GNTI-122, derived from a participant's own blood cells, is safe and effective in managing T1D. Participants will be divided into groups to receive different doses of the treatment, with one group also receiving a medication called rapamycin. Suitable candidates are adults diagnosed with T1D in the last four months, who still produce some insulin and test positive for a specific genetic marker (HLA-DRB1*04:01). As a Phase 1 trial, this research focuses on understanding how GNTI-122 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that GNTI-122 is likely to be safe for humans?

Research shows that GNTI-122 is designed to help people with type 1 diabetes by using their own cells to protect insulin-producing cells. This treatment targets special immune cells called Tregs, which can calm the immune system.

Although information on GNTI-122's safety in humans is limited, this study is in its early stages, known as Phase 1. The main goal at this stage is to determine if the treatment is safe and well-tolerated. Phase 1 trials usually involve small groups to closely monitor responses to the treatment.

Prospective participants will be closely monitored for any side effects, including regular check-ups, blood tests, and other health assessments to ensure safety throughout the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Type 1 Diabetes, which often involve insulin therapy to manage blood sugar levels, GNTI-122 is unique because it targets the underlying immune response that causes the disease. Researchers are excited about GNTI-122 as it aims to preserve the insulin-producing cells in the pancreas by modulating the immune system. This approach not only has the potential to reduce the need for insulin injections but also addresses the root cause of Type 1 Diabetes, which could lead to more effective long-term management of the condition.

What evidence suggests that GNTI-122 might be an effective treatment for Type 1 Diabetes?

Research has shown that GNTI-122, a specially designed cell therapy, could benefit individuals recently diagnosed with Type 1 Diabetes (T1D). This treatment uses the patient's own blood cells to help the immune system protect insulin-producing cells in the pancreas. Studies have found that these modified cells can help balance the immune system and may slow damage to insulin-producing cells. Early results suggest that GNTI-122 can reduce immune system attacks, which is crucial for managing T1D. This therapy aims to help the body continue producing insulin for a longer time, slowing the condition's progression. ^{1 2 3 4 6}

Who Is on the Research Team?

Mark Bach, MD

Principal Investigator

GentiBio, Inc

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: GNTI-122 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

GentiBio, Inc

Lead Sponsor

Trials

1

Recruited

50+

Citations

1. insight.jci.org insight.jci.org/articles/view/171844

GNTI-122: an autologous antigen-specific engineered ... Tregs have the potential to establish long-term immune tolerance in patients recently diagnosed with type 1 diabetes (T1D) by preserving β ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06919354

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

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11063937/

GNTI-122: an autologous antigen-specific engineered Treg ... Tregs have the potential to establish long-term immune tolerance in patients recently diagnosed with type 1 diabetes (T1D) by preserving β cell ...

4. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/2132-LB/158864/2132-LB-GNTI-122-A-Clinic-Ready-Advanced-Treg

2132-LB: GNTI-122—A Clinic-Ready Advanced Treg Therapy ... GNTI-122 represents a promising therapeutic to halt progression of recently diagnosed T1D. Finally, GentiBio has designed the Polaris study, a ...

5. diabetesresearchclinicalpractice.com diabetesresearchclinicalpractice.com/article/S0168-8227(23)00122-5/fulltext

IDF2022-0687 Characterization and efficacy of GNTI-122 ... Conclusion. GNTI-122 overcomes the key limitations of sorted Treg cell therapy, demonstrating direct and bystander suppression in vitro and efficacy in vivo, ...

6. gentibio.com gentibio.com/pipeline-programs/new-onset-t1d/

GNTI-122 GNTI-122 is an autologous engineered Tregs (EngTregs™) product designed to protect beta cells from destruction by the immune system. GNTI-122 is being ...