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Systemic Lupus ErythematosusPhase 1NCT06544330

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 testing SYNCAR-001 and STK-009 in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Synthekine at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
SYNCAR-001 and STK-009
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
6 sitesUnited States
Study dates
29 Apr 2025to Apr 2041
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

General Inclusion Criteria:

Age ≥18 years at screening.

SLE Inclusion Criteria:

  1. Clinical diagnosis of SLE according to the 2019 European League Rheumatism EULAR/ACR classification criteria.
  2. Subject must be positive for at least one of the following at screening: Anti-dsDNA (above the upper limit of normal [ULN]); or anti-Sm (above the ULN); or anti-Chromatin (above the ULN).
  3. Subjects with active, severe, non-renal SLE or subjects with active proliferative LN

SSc Inclusion Criteria:

  1. Classified as SSc according to the ACR/EULAR classification criteria.
  2. Diffuse cutaneous SSc (dcSSc) or SSc-associated ILD (SSc-ILD; significant or progressive).

General Exclusion Criteria:

  1. History of or active central nervous system manifestations of autoimmune disease.
  2. Prior treatment with anti-CD19 adoptive T cell therapy, or any prior gene therapy product (e.g., CAR T cell therapy).

SLE Exclusion Criteria:

  1. Rapidly progressive glomerulonephritis.
  2. End stage renal failure requiring dialysis or most recent renal biopsy with purely chronic lesions (Class III[C], IV-S[C], or IV-G[C]) if isolated renal disease.

SSc Exclusion Criteria:

  1. FVC <50% of predicted or DLCO <40% of predicted.
  2. Pulmonary arterial hypertension (PAH) requiring PAH-specific treatment.

Other protocol-defined criteria apply.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Feinstein Institutes for Medical Research

    Manhasset, New York, 11030

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Phase 1, Open-Label Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy (SYNCAR-001 + STK-009) 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.

Read the detailed description

SYNCAR-001 + STK-009 is a 2-component human orthogonal (ho) IL-2 receptor-ligand cell therapy consisting of (1) SYNCAR-001, a CD19-directed chimeric antigen receptor T cell (CAR-T) co-expressing an engineered IL-2 beta receptor (hoRb); and (2) STK-009, an engineered pegylated IL-2 cytokine (hoIL-2) selective for hoRb. This study is being conducted to evaluate the safety and efficacy of a single dose of SYNCAR-001 followed by multiple subcutaneously administered doses of STK-009. No conditioning chemotherapy (lymphodepletion) will be administered. The study will follow a 3+3 design during dose escalation followed by dose expansion at the recommended phase 2 dose (RP2D).

Being tested
SYNCAR-001, STK-009
Keywords
CAR T, CD19-CAR T, Chimeric antigen receptor, IL-2
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Nephritis, Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SYNCAR-001Drug

    SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb

  • STK-009Drug

    STK-009 is a human orthogonal IL-2 cytokine selective for SYNCAR-001 CAR-T cells expressing hoRb

Study groups in NCT06544330
Study groupRoleWhat they receive
SYNCAR-001 + STK-009ExperimentalDose escalation: A single fixed dose of autologous SYNCAR-001 CAR-T intravenously (IV) will be administered in combination with ascending doses of STK-009 subcutaneously (SC) in non-lymphodepleted patients. Dose expansion: A single fixed dose of autologous SYNCAR-001 CAR-T IV will be administered in combination with STK-009 SC at the RP2D in non-lymphodepleted patients.
Receives: Drug: SYNCAR-001; Drug: STK-009

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Limiting Toxicities (DLTs)

    Incidence of adverse events (AEs) meeting protocol defined DLT criteria in the dose escalation phase of the study.

    Measured: Up to 28 days after SYNCAR-001 infusion

  2. Adverse Events

    Incidence and severity of AEs including treatment-emergent AEs and serious AEs.

    Measured: Up to 96 weeks after SYNCAR-001 infusion

Secondary outcomes (11)

  1. Remission rate per Definition of Remission in SLE (DORIS)

    For SLE only

    Measured: Up to 96 weeks after SYNCAR-001 infusion

  2. Lupus Low Disease Activity State (LLDAS) attainment rate

    For SLE only

    Measured: Up to 96 weeks after SYNCAR-001infusion

  3. Change over time in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)

    For SLE only. The SLEDAI-2K assessment consists of 24 items with a total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores indicating increased disease activity.

    Measured: Up to 96 weeks after SYNCAR-001 infusion

  4. Change over time in British Isles Lupus Activity Group (BILAG) score

    For SLE only. The BILAG instrument assesses 97 clinical signs, symptoms, and laboratory parameters across 9 organ system domains related to SLE. BILAG scoring represents: A=severe disease, B=moderate disease, C=stable mild disease, D=inactive but previously active disease, E=never involved.

    Measured: Up to 96 weeks after SYNCAR-001 infusion

  5. Change over time in levels of SLE and SSc serum autoantibodies

    Measured: Up to 96 weeks after SYNCAR-001 infusion

  6. Complete renal response rate (CRR)

    Lupus Nephritis only. CRR will be defined as a UPCR < 0.5 and no eGFR decrease > 15% from baseline.

    Measured: Up to 96 weeks after SYNCAR-001 infusion

  7. Change over time in Modified Rodnan Skin Score (mRSS)

    Systemic Sclerosis only. mRSS measures skin thickness and is the sum of scores from 17 surface anatomic areas rated on a 0-3 scale (0=normal skin; 1=mild thickness; 2=moderate thickness; 3=severe thickness with inability to pinch the skin into a fold). mRSS ranges from 0 (best possible outcome) to 51 (worst possible outcome)

    Measured: Up to 96 weeks after SYNCAR-001 infusion

  8. Proportion of subjects achieving revised Composite Response Index in Systemic Sclerosis (rCRISS-25) criteria

    Systemic Sclerosis only. rCRISS-25 is the proportion of patients who improve in ≥ 2/5 ACR CRISS core items by 25% (except 5% for FVC) with no worsening of 1 core item

    Measured: Up to 96 weeks after SYNCAR-001 infusion

  9. Proportion of subjects achieving rCRISS-25 criteria with no immunosuppressive therapy.

    Systemic Sclerosis only

    Measured: Up to 96 weeks after SYNCAR-001 infusion

  10. Change over time in pulmonary function tests

    Systemic Sclerosis only. Pulmonary function tests include % predicted FVC (Forced Vital Capacity) and % predicted DLCO (Diffusing capacity of the lung for carbon monoxide)

    Measured: Up to 96 weeks after SYNCAR-001 infusion

  11. Change over time in high resolution computed tomography of the chest for subjects with interstitial lung disease.

    Systemic Sclerosis only. High resolution computed tomography images of the chest will be scored according to changes in interstitial lung disease using validated qualitative and quantitative methods

    Measured: Up to 96 weeks after SYNCAR-001 infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start29 Apr 2025
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2041 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06544330
Sponsor's protocol ID
STK-009-201
Status last verified
Oct 2025
First submitted
25 Jul 2024
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SYNCAR-001 and STK-009 in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Synthekine at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicities (DLTs) (time frame: Up to 28 days after SYNCAR-001 infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06544330.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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