CNP-103: tolerogenic nanoparticles in recent-onset T1D
What this study tests
A recruiting Phase 1b/2a trial of CNP-103, a nanoparticle-based therapy designed to induce antigen-specific immune tolerance in recent-onset T1D. An ADA 2026 abstract reports early tolerability in the first six adults, without a clinical C-peptide efficacy result.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-09-11.
Most recent recorded citation date: 2026-09-11. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Ages 12-35 with stage 3 type 1 diabetes diagnosed within the previous 180 days, and a peak stimulated C-peptide above 0.2 nmol/L on a screening mixed-meal tolerance test — that is, still making a measurable amount of their own insulin. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- An ADA 2026 abstract reports only the first 100 mg adult cohort: six adults received doses on days 1 and 8, with no infusion interruptions or serious adverse events. Sinus discomfort, presyncope, decreased neutrophil count, and low vitamin D were the most common reported events; none was judged related to study product. This is an early cohort safety signal, not an efficacy result. The 72-person trial remains recruiting, with primary completion estimated in December 2026.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Primary endpoints
- Frequency of adverse events and serious adverse events, from day 1 through day 365
- Immune safety, measured as serum cytokines (IL-1-beta, TNF-alpha, IL-6, MCP-1, MIP-1-alpha, IFN-gamma, IL-4, IL-10)
The full picture
What this trial is testing
COUR describes CNP-103 as a nanoparticle therapy intended to induce antigen-specific tolerance and protect remaining beta cells. The company and the conference abstract describe four recombinant islet proteins, but a clinical result showing selective immune tolerance or preserved insulin secretion has not been reported here.23 Fast Track designation is not marketing approval.
Who is eligible
The September 2026 registry selects ages 12–35, stage 3 T1D diagnosed within 180 days, and peak stimulated C-peptide above 0.2 nmol/L on a mixed-meal test. Adolescent dose cohorts follow the corresponding adult cohort and safety review. The trial plans 72 participants; this is not a treated or efficacy-analysis denominator. Dosing is intravenous on days 1, 8 and 90, followed by assessment through one year.1
The registry and sponsor list recruitment as active. Current eligibility and availability must be confirmed with a study site. The sponsor page gives inconsistent site counts and participation durations, so those figures are not treated as settled facts here.4
Results and their limits
ADA 2026 abstract 2419-P describes six adults in the first 100 mg dose cohort after day-1 and day-8 dosing. It reports no infusion interruptions or serious adverse events. The common reported events were sinus discomfort, presyncope, decreased neutrophil count and low vitamin D; none was judged product-related.2
The cohort was part of a placebo-controlled dose-escalation design. These pooled early observations do not establish a drug-versus-placebo safety difference, overall safety, clinical C-peptide preservation or insulin independence. The abstract includes sponsor-employed authors and is a conference report, not a full peer-reviewed clinical paper. No complete trial results are posted in the registry.12
What remains to be answered
The primary outcomes concern adverse events and immune safety. C-peptide and immune-cell findings are exploratory and could provide a preliminary signal, but the early study cannot by itself establish a durable cure. Primary completion is estimated for December 2026, with study completion in June 2027; estimated dates may change.1
Sources
- [1]CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed Stage 3 Type 1 Diabetes · Trial registry · 2026-09-11 — Registry update posted 11 September 2026; retrieved 16 September 2026. Recruiting, n=72 estimated. This is protocol and status information, not a complete clinical outcomes report.
ClinicalTrials.gov. NCT06783309. Registry update 11 September 2026; retrieved 16 September 2026.
- [2]CNP-103: A First-in-Human Phase 1b/2a Study of an Antigen-Specific, Immune-Tolerizing Therapy for Recent-Onset Type 1 Diabetes · Conference finding · 2026-06-05 — ADA 2026 abstract 2419-P. Reports six adults in the 100 mg cohort after day-1 and day-8 dosing: no infusion interruptions or serious adverse events, and no reported events judged product-related. It does not report C-peptide efficacy.
Patel SK, et al. ADA 2026 abstract 2419-P. Published 5 June 2026; publisher-deposited abstract retrieved through Crossref.
- [3]COUR pipeline and CNP-103 intended immune-tolerance mechanism · Manufacturer — Company mechanism and designation claims, not demonstrated T1D benefit.
COUR Pharmaceuticals. CNP-103 pipeline description.
- [4]COUR CNP-103 clinical trial information · Manufacturer — Current enrolment information; site counts and participation duration conflict within the page, so they are not reproduced here.
COUR Pharmaceuticals. CNP-103 clinical trial information.