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Cytokine

SYNCAR-001 + STK-009 for Lupus

Phase 1

Recruiting

Research Sponsored by Synthekine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Subjects with active, severe, non-renal SLE or subjects with active proliferative LN

Must not have

History of or active central nervous system lupus

Rapidly progressive glomerulonephritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days after syncar-001 infusion

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new combination of drugs, SYNCAR-001 and STK-009, in patients with severe and difficult-to-treat lupus."

Who is the study for?

This trial is for adults over 18 with severe, treatment-resistant systemic lupus erythematosus (SLE). Participants must have a clinical diagnosis of SLE and test positive for certain autoantibodies. It's not suitable for those with mild SLE or conditions that could interfere with the study.

What is being tested?

The trial is testing SYNCAR-001 combined with STK-009 as a potential treatment for severe SLE. This phase 1 study aims to evaluate the safety and how well patients tolerate this combination therapy.

What are the potential side effects?

As this is an early-phase trial, specific side effects are being studied; however, CAR-T therapies can cause immune reactions, fever, fatigue, and infusion-related symptoms. IL-2 may lead to flu-like symptoms and low blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I tested positive for at least one specific antibody related to my condition.

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I have severe lupus not affecting my kidneys or active kidney lupus.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had lupus affecting my brain or spinal cord.

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My kidney disease is worsening quickly.

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I am on dialysis or my latest kidney biopsy showed chronic damage.

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I have previously received CAR T cell therapy or similar treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days after syncar-001 infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days after syncar-001 infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after syncar-001 infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Dose-Limiting Toxicities (DLTs)

Secondary study objectives

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

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

Complete renal response rate (CRR)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SYNCAR-001 + STK-009Experimental Treatment2 Interventions

Dose 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.

0 / 7Eligibility criteria met