Hawthorne, NYNCT07328581Now EnrollingIRB Ready

Systemic Lupus Erythematosus (SLE) Clinical Trial in Hawthorne, NY

Access cutting-edge systemic lupus erythematosus (sle) treatment through this phase 2 clinical trial at a research site in Hawthorne. Study-provided care at no cost to qualified participants.

Sponsored by iCell Gene Therapeutics

Quick Self-Assessment

See if you qualify for this Hawthorne location

Preparing your pre-screening questions…

Expert Care in Hawthorne

Access systemic lupus erythematosus (sle) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related systemic lupus erythematosus (sle) treatment provided free

Apply for This Hawthorne Location

Check if you qualify for this systemic lupus erythematosus (sle) clinical trial in Hawthorne, NY

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Hawthorne

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Hawthorne site if eligible
  4. 4Begin participation

About This Systemic Lupus Erythematosus (SLE) Study in Hawthorne

This Phase IIa, open-label, single-arm study includes an initial Safety Run-In followed by dose expansion to evaluate the safety, tolerability, cellular kinetics, pharmacodynamics, and preliminary clinical activity of a single infusion of ICG318 in participants with refractory SLE, with or without LN. Participants will receive protocol-specified lymphodepletion followed by ICG318 at the recommended Phase 2 dose.

Sponsor: iCell Gene Therapeutics

Who Can Participate

Inclusion Criteria

Age 16-70 years at the time of signing the informed consent
Have a diagnosis of SLE by EULAR/ACR 2019 criteria for ≥6 months.
Have at least one of an antinuclear antibody, anti-double-stranded deoxyribonucleic acid (dsDNA), or elevated anti-Smith (Sm) antibody
Inadequate response to 2 prior standard of care therapies, used for at least three months
SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥7 at Screening
For LN cohort participants. Kidney biopsy result within 6 months prior to Screening indicating Class III or IV (alone or in combination with Class V). Key

Exclusion Criteria

Any acute, severe lupus related flare that needs immediate treatment
History of antiphospholipid syndrome with thromboembolic event within 12 months
History or current diagnosis of any disease, condition or treatment that may confound clinical assessments in the study.
Has drug-induced SLE.
History of prior CAR-T therapy.
History of bone marrow/hematopoietic stem cell or solid organ transplant or planned receipt during the study period.
Recent serious or ongoing infection, or risk for serious infection, or acute or chronic infection
Receipt of a live/live-attenuated vaccine other than BCG within 8 weeks
History within the past year or current clinically significant central nervous system disease, including but not limited to cerebrovascular accident, seizures, severe brain injury, dementia, Parkinson's disease, cerebellar disease, or multiple sclerosis
Impaired cardiac function or clinically significant cardiac disease
End stage renal disease or severe liver disease
Breastfeeding/lactating or pregnant women or women who intend to become pregnant at any time during the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Hawthorne?

Yes, this clinical trial (NCT07328581) has an active research site in Hawthorne, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Systemic Lupus Erythematosus (SLE) Treatment Options in Hawthorne, NY

If you're searching for systemic lupus erythematosus (sle) treatment options in Hawthorne, NY, this clinical trial (NCT07328581) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Hawthorne research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced systemic lupus erythematosus (sle) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all systemic lupus erythematosus (sle) clinical trials near you to find additional studies recruiting in your area.

More Heart Attack Trials in Hawthorne, NY

See all heart attack clinical trials recruiting in Hawthorne — not just this study.

Browse Heart Attack Trials in Hawthorne →

Browse More Trials by Condition

Heart Attack TrialsLupus TrialsInterstitial Cystitis TrialsSystemic Lupus Erythematosus TrialsMyocardial Infarction TrialsAll Conditions →

Ready to Join in Hawthorne?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Hawthorne, NY