Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 1

A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease

NCT06544330 · View on ClinicalTrials.gov ↗

Study Summary

This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.

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

FieldValue
Enrollment Target 48 participants
Start Date 2025-04-29
Est. Completion 2041-04
Phase Phase 1

Sponsor

Synthekine

3 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06544330

The ClinicalTrials.gov registry entry for NCT06544330 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Synthekine, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06544330 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Ohio, Arizona, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06544330?

The interventions under investigation include: SYNCAR-001 (DRUG), STK-009 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06544330?

This trial is sponsored by Synthekine, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial