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NCT06544330 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease
A Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis, sponsored by Synthekine.
- Active
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 5
- Study locations
NCT06544330: Active Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis, sponsored by Synthekine.
NCT06544330 is a Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis that is active but no longer recruiting, run by Synthekine. The registered enrollment target is 48 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (87% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06544330, a Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis, is active but no longer recruiting, sponsored by Synthekine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.
Primary Outcome
Incidence of adverse events (AEs) meeting protocol defined DLT criteria in the dose escalation phase of the study.
Conditions Studied
Interventions
- DRUG SYNCAR-001
- DRUG STK-009
Study Locations (5)
Ohio
- The Cleveland Clinic Foundation - Cleveland
- Ohio State University Wexner Medical Center - Columbus
Arizona
- HonorHealth Research Institute - Scottsdale
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- Feinstein Institutes for Medical Research - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2025-04-29 |
| Est. Completion | 2041-04 |
| Phase | Phase 1 |
What the registry record for NCT06544330 still lists
NCT06544330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which SYNCAR-001 is the first listed.
NCT06544330 lists 5 locations in 4 states (Ohio, Arizona, New Jersey).
Frequently Asked Questions
What is clinical trial NCT06544330 about?
NCT06544330 is a clinical study titled "A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease". This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.
What is the current status of trial NCT06544330?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2025-04-29. Estimated completion is 2041-04.
What conditions does trial NCT06544330 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis.
What interventions are being tested in trial NCT06544330?
The interventions under investigation include: SYNCAR-001 (DRUG), STK-009 (DRUG).
Who is sponsoring clinical trial NCT06544330?
This trial is sponsored by Synthekine, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06544330 being conducted?
This trial has 5 study locations across Arizona, New Jersey, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06544330's enrollment target sits among peer trials
48 71st of 99 higher than 28 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus 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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