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NCT04590872 · ClinicalTrials.gov registry record · Phase 1
An Immunotherapy Vaccine (PIpepTolDC) for the Treatment of Patients With Type 1 Diabetes
A Phase 1 study of Type 1 Diabetes Mellitus, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT04590872: Active Phase 1 study of Type 1 Diabetes Mellitus, sponsored by City of Hope Medical Center.
NCT04590872 is a Phase 1 study of Type 1 Diabetes Mellitus that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 6 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04590872, a Phase 1 study of Type 1 Diabetes Mellitus, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial investigates the side effects of PIpepTolDC vaccine in treating patients with type 1 diabetes who use insulin and don't have any other diabetes-related health complications. Type 1 diabetes is an autoimmune disease. This means that the immune system, which usually protects against foreign invaders like bacteria and viruses, attacks the body's insulin-producing betacells in the pancreas (autoimmune response). Overtime, the beta cells are destroyed by the immune system. To stay alive, people with type 1 diabetes must use insulin. PIpepTolDC vaccine is a type of immunotherapy (a treatment that uses a person's own immune system) that works like an allergy shot. The vaccine is made using one's own immune cells (dendritic cells) and a beta cell protein. The vaccine may teach the immune system to stop attacking the beta cells, which may help the beta cells recover and make enough insulin to control blood sugar levels. The vaccine may also help reduce future type 1 diabetes related complications.
Primary Outcome
Toxicity and adverse events (except hypoglycemia and diabetic ketoacidosis \[DKA\]) will be recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Hypoglycemia events and DKA will be defined per American Diabetes Association (ADA) grading systems.Observed toxicities will be summarized by type, severity (by CTCAE v 5.0 and nadir or maximum values for lab measures), date of onset, duration, reversibility, and attribution.
Conditions Studied
Interventions
- BIOLOGICAL Tolerogenic Dendritic Cell Vaccine
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2022-06-16 |
| Est. Completion | 2026-12-15 |
| Phase | Phase 1 |
What the registry record for NCT04590872 still lists
NCT04590872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Tolerogenic Dendritic Cell Vaccine is the first listed.
NCT04590872 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04590872 about?
NCT04590872 is a clinical study titled "An Immunotherapy Vaccine (PIpepTolDC) for the Treatment of Patients With Type 1 Diabetes". This phase I trial investigates the side effects of PIpepTolDC vaccine in treating patients with type 1 diabetes who use insulin and don't have any other diabetes-related health complications. Type 1 diabetes is an autoimmune disease. This means that the immune system, which usually protects against...
What is the current status of trial NCT04590872?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2022-06-16. Estimated completion is 2026-12-15.
What conditions does trial NCT04590872 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT04590872?
The interventions under investigation include: Tolerogenic Dendritic Cell Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04590872?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04590872 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04590872's enrollment target sits among peer trials
6 113th of 112 the lowest of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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