Miami, FLNCT06919354Now EnrollingIRB Ready

Type 1 Diabetes (T1D) Clinical Trial in Miami, FL

Access cutting-edge type 1 diabetes (t1d) treatment through this clinical trial at a research site in Miami. Study-provided care at no cost to qualified participants.

Sponsored by GentiBio, Inc

Quick Self-Assessment

See if you qualify for this Miami location

Preparing your pre-screening questions…

Expert Care in Miami

Access type 1 diabetes (t1d) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related type 1 diabetes (t1d) treatment provided free

Apply for This Miami Location

Check if you qualify for this type 1 diabetes (t1d) clinical trial in Miami, FL

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Miami

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Miami site if eligible
  4. 4Begin participation

About This Type 1 Diabetes (T1D) Study in Miami

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. Visit https://www.polarisstudy.com to learn more!

Sponsor: GentiBio, Inc

Who Can Participate

Inclusion 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 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

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT06919354) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Type 1 Diabetes (T1D) Treatment Options in Miami, FL

If you're searching for type 1 diabetes (t1d) treatment options in Miami, FL, this clinical trial (NCT06919354) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this clinical trial. You'll receive care from experienced type 1 diabetes (t1d) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all type 1 diabetes (t1d) clinical trials near you to find additional studies recruiting in your area.

More Pulmonary Embolism Trials in Miami, FL

See all pulmonary embolism clinical trials recruiting in Miami — not just this study.

Browse Pulmonary Embolism Trials in Miami

Ready to Join in Miami?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Miami, FL