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NCT06298019 · ClinicalTrials.gov registry record · Phase 1
Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis
A Phase 1 study of Dermatomyositis, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 2
- Study locations
NCT06298019: Recruiting Phase 1 study of Dermatomyositis, sponsored by Stanford University.
NCT06298019 is a Phase 1 study of Dermatomyositis that is actively recruiting participants, run by Stanford University. The registered enrollment target is 21 participants, below the 484-participant average among 19 other Dermatomyositis trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06298019, a Phase 1 study of Dermatomyositis, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this clinical trial is to characterize to understand the effects of a type of cell therapy called Chimeric Antigen Receptor T lymphocyte (CAR T) therapy in adult patients with the autoimmune disease dermatomyositis. This study will utilize a technology that modifies a type of white blood cell called the cytotoxic T lymphocyte-this T cell normally functions in the immune system to kill infected or potentially harmful cells in the body. In CAR T therapy, the patients' white blood cells are harvested and the cytotoxic T cells are isolated and modified such that they are programmed to kill any cell that has a protein structure called "CD19" on its outer surface (membrane). Since the CD19 protein is only present on a type of white blood cell called the B lymphocyte, when these "re-engineered" cytotoxic T lymphocytes are then given back to the patient (by an infusion), these cells will seek out and kill essentially all of the patient's B cells. B cells are an important part of a person's immune system and have many functions, including the production of antibodies. It is thought that, in dermatomyositis and other autoimmune diseases, a tiny subset of these B cells plays a large role in making autoantibodies (antibodies directed against the patient's own tissues) and causing disease. The idea is that the therapy will "wipe out" all/most of the B cells in the patient so that they can make an entirely new set of B cells to recreate a functional immune system without the autoimmune disease. The main questions the study intends to answer are: * Understanding how well patients tolerate undergoing this therapy in terms of side effects; * Getting an early idea if this therapy can help certain aspects of the autoimmune disease, including inflammation in the skin, muscles, and lungs;
Primary Outcome
This outcome is to characterize the safety and tolerability of administering KYV-101 CAR T cells that meet the established criteria to patients with DM. Participants experiencing adverse events including laboratory abnormalities will be reported.
Conditions Studied
Interventions
- BIOLOGICAL KYV-101
Study Locations (2)
California
- Stanford University - Palo Alto
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-08-02 |
| Est. Completion | 2039-04 |
| Phase | Phase 1 |
What NCT06298019 shows while recruiting
NCT06298019 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 484-participant average among 19 other Dermatomyositis trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Dermatomyositis appearing as the primary indexed condition, and to 1 intervention - of which KYV-101 is the first listed.
NCT06298019 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06298019 about?
NCT06298019 is a clinical study titled "Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis". The goal of this clinical trial is to characterize to understand the effects of a type of cell therapy called Chimeric Antigen Receptor T lymphocyte (CAR T) therapy in adult patients with the autoimmune disease dermatomyositis. This study will utilize a technology that modifies a type of white blood...
What is the current status of trial NCT06298019?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2024-08-02. Estimated completion is 2039-04.
What conditions does trial NCT06298019 study?
This clinical trial studies the following conditions: Dermatomyositis.
What interventions are being tested in trial NCT06298019?
The interventions under investigation include: KYV-101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06298019?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06298019 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06298019's enrollment target sits among peer trials
21 16th of 19 higher than 4 of 19 other Dermatomyositis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dermatomyositis 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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