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Personalized cell therapy aims to tame type 1 diabetes in early trial

NCT ID NCT06919354

Disease control Sponsor: GentiBio, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This early-stage study is testing a new treatment called GNTI-122 for adults who were recently diagnosed with type 1 diabetes. The therapy is made from a person's own blood cells and is designed to help rebalance the immune system. Sixteen participants will receive either a low or high dose of GNTI-122, with some also getting the drug rapamycin, and will be followed for 78 weeks to check safety and how well it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GNTI-122 (a cell therapy made from the patient's own blood cells, sometimes given with rapamycin)
What this could lead to
If successful, this could point toward a way to help people with newly diagnosed type 1 diabetes better control their blood sugar and reduce reliance on insulin.
What could go wrong
This is a very early, small study (16 people) focused mainly on safety. It may not show clear benefits, and the cell therapy might not work as hoped or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female participants aged ≥18 to ≤55 years with recently diagnosed (within 180 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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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes (T1D) Type 1 diabetes mellitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Columbia University

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

    Contact Email: •••••@•••••

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Joslin Diabetes Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

    Contact Email: •••••@•••••

  • University of California - San Diego

    RECRUITING

    San Diego, California, 92093-0990, United States

    Contact Email: •••••@•••••

  • University of California - San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

    Contact Email: •••••@•••••

  • University of Florida - Gainesville

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Miami, Diabetes Research Institute

    RECRUITING

    Miami, Florida, 33136, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

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