Explore a Clinical Study for Your Patients Living with Type 1 Diabetes (T1D)

The CNP-103 Clinical Trial is researching the safety, tolerability, pharmacodynamics, and efficacy of an investigational therapy, CNP-103, in participants ages 12–35 with recent onset Stage 3 T1D. The investigational drug is not approved for use by any health authority.

About the CNP-103 Clinical Trial

This is a phase 1b/2a, randomized, double-blind, placebo-controlled study that is enrolling approximately 72 participants across 2 phases. The phase 1b dose-escalation portion will recruit 36 participants randomized at a 2:1 ratio (active:placebo), followed by a phase 2a expansion phase of 36 participants with a 3:1 ratio.

The total duration of participation will last approximately 13 months, including a screening period (28 days), treatment period (90 days), and follow-up period (275 days). All participants will attend 10 study site visits throughout the study duration.

The investigational study therapy, CNP-103, is administered via IV infusion on Days 1, 8, and 90 during the dose-escalation phase. Expansion phase dosing will be established based on results from the dose-escalation phase.

During the dose-escalation phase, participants receive CNP-103 or placebo on Days 1, 8, and 90, followed by post-dosing evaluations to assess safety and tolerability across dose levels.

In the expansion phase, participants receive CNP-103 or placebo using a dosing schedule and dose level(s) selected based on dose-escalation-phase results.

Study Design

Throughout the study, participants will be closely monitored and will visit the research site regularly for assessments, procedures, and health checks.

Screening: 28 Days

Treatment: 90 Days

Follow-Up: 275 Days

The total duration of participation will last about 13 months, including a screening period (28 days), treatment period (90 days), and follow-up period (275 days). Participants will attend 10 study site visits throughout their participation.

Key Eligibility Criteria

Inclusion

Eligible participants must:

  • Be 12–35 years of age (inclusive)
  • Have a documented diagnosis of Stage 3 T1D within 180 days prior to study enrollment according to ADA criteria
  • Be on standard-of-care diabetes management including insulin therapy as a routine, a nutrition plan, regular exercise, or other relevant specialty care
  • Have peak stimulated C-peptide > 0.2 nmol/L measured from a Mixed Meal Tolerance Test (MMTT)
  • Be free from systemic corticosteroids or any medication used to treat symptoms of T1D (other than insulin) for at least 2 weeks prior to enrollment, and agree to use a nonsteroid alternative throughout the study

Exclusion

Eligible participants must not use certain medications and must not have any of the following:

  • Within 90 days prior to first dose, whichever is shorter:
    • Oral immunomodulators: cyclosporin, azathioprine, methotrexate
    • Other antidiabetic agents besides insulin within 90 days prior to screening
  • Within 12 months prior to first dose:
    • T cell–modifying immunotherapy (e.g., abatacept, etanercept, ustekinumab)
    • T cell–depleting immunotherapy (e.g., teplizumab)
  • History of or currently active immune disorders other than T1D (including autoimmune disease), unless deemed acceptable by the medical monitor
  • Pregnancy
  • Significant comorbid conditions which, in the investigator’s opinion, make the participant unsuitable for study participation

Additional eligibility criteria, according to approved protocol, will apply.

About the Study Therapy

CNP-103 is an investigational therapy being evaluated to determine whether antigen-specific immune tolerance can reduce autoimmune-mediated β cell destruction and preserve endogenous insulin production in patients with recent-onset type 1 diabetes (T1D).1,2

Exogenous insulin remains the standard of care for T1D but only provides symptomatic glucose control and requires lifelong administration without addressing the underlying autoimmune process.3

CNP-103 is designed to induce immune tolerance to the 4 major beta cell autoantigens in T1D by addressing the heterogeneity of autoimmune responses observed in T1D including1,2:

  • Preproinsulin (PPI)
  • Glutamic acid decarboxylase 65 (GAD65)
  • Islet-specific glucose-6-phosphatase catalytic subunit-related protein (IGRP)
  • Zinc Transporter 8 (ZnT8)

Sustained β cell function has been shown to be associated with improved glycemic control and a reduced risk of hypoglycemia, diabetes ketoacidosis, and long-term complications.4 By halting the autoimmune-mediated destruction of pancreatic β cells, CNP-103 has the potential to preserve beta cell function and consequently endogenous insulin secretion.1,2,3

How CNP-103 Works

Mechanism of Action Harnesses Normal Bioclearance and Tolerance Pathway.2,3

COUR nanoparticles (CNPs)

CNPs mimic apoptotic bodies based on size (~500 nm) and negative charge leading to tolerogenic signal.

1. CNPs Are Administered via IV

2. In the Liver and Spleen

Negatively charged CNPs are phagocytosed by antigen-presenting cells (APCs), where they are degraded, and the peptide fragments are then presented to T cells on the surface via Major Histocompatibility Complex (MHC).

3. APCs Present Antigens

APCs present the antigens in the context of the tolerogenic signal, resulting in antigen-specific reprogramming of pathogenic T cells. T cells then undergo deletion, anergy, or activate a T-regulatory (Treg) response through this endogenous mechanism for maintaining peripheral tolerance.

Tregs traffic to site of disease

4. Site of Disease

Down regulation of autoimmune activity at disease sites: These effects are intended to reduce immune-mediated/T cell mediated β cell destruction in pancreatic islets.4

Type 1 Diabetes Pancreatic Islet Cells

The CNP-103 Clinical Trial evaluates whether targeted, antigen-specific immune tolerance can:

  • Modify the underlying autoimmune process in Stage 3 T1D (pharmacodynamics)
  • Preserve remaining endogenous insulin secretion (efficacy)

Refer a Patient

If you have a patient who you think may qualify for this study, please refer them to take the prescreening questionnaire to determine their eligibility.

Find and Contact a Site Near You

Enter your zip code to find the participating research site(s) nearest you. You can also view the full list of participating research sites to determine which site you’re interested in referring a patient to.

Active site locations

Future site locations

Study Resources

Explore these resources to learn more about the CNP-103 Clinical Trial. They can further help you understand the study and decide whether participation may be right for your patients.

HCP Flyer

Download the HCP study flyer to learn more about the CNP-103 Clinical Trial.

Download

Patient Brochure

Download the patient-friendly brochure about the CNP-103 Clinical Trial to share with eligible patients.

Download

References

  1. Roep BO, Wheeler DC, Peakman M. Antigen-based immune modulation therapy for type 1 diabetes: the era of precision medicine. Lancet Diabetes Endocrinol. 2019;7(1):65-74. doi:10.1016/S2213-8587(18)30109-8.↵
  2. Podojil JR, Genardi S, Chiang MY, et al. Tolerogenic immune-modifying nanoparticles encapsulating multiple recombinant pancreatic β cell proteins prevent onset and progression of type 1 diabetes in nonobese diabetic mice. J Immunol. 2022;209(3):465-475. doi:10.4049/jimmunol.2200208.↵
  3. Jamison BL, Neef T, Goodspeed A, et al. Nanoparticles containing an insulin-ChgA hybrid peptide protect from transfer of autoimmune diabetes by shifting the balance between effector T cells and regulatory T cells. J Immunol. 2019;203(1):48-57. doi: 10.4049/jimmunol.1900127.↵
  4. Lachin J. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC). Version 21, NIDDK Central Repository; 2021. doi:10.58020/mn8k-ms49.↵