A Study of GNTI-122 in Adults Recently Diagnosed With T1D
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGentiBio, Inc
About 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. Visit https://www.polarisstudy.com to learn more!
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
GNTI-122
Biological/VaccineGNTI-122 is an investigational cell therapy manufactured from a participant's own blood cells and is intended to help correct an imbalance of certain types of cells found in participants with Type 1 Diabetes.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: GNTI-122Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D
Cumulative AEs/SAEs and clinically significant abnormalities in physical exams, vital signs, clinical laboratory measures, and other clinical assessments
Time frame
Week 78Secondary outcomes
1
Cellular kinetics of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D
Measurement of maximum concentration of circulating engineered regulatory T cells as measured by droplet digital polymerase chain reaction
Time frame
Week 782
Cellular kinetics of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D
Measurement of area under the concentration-time curve \[AUC\] of circulating engineered regulatory T cells
Time frame
Week 783
Cellular kinetics of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D
Measurement of half-life of circulating engineered regulatory T cells
Time frame
Week 78Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov