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RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus

RESET-SLE: A study testing CABA-201 safety in lupus patients.

Recruiting
18-65 years
All
Phase 1/2

RESET-SLE is a study for adults with Systemic Lupus Erythematosus (SLE), a long-term disease where the immune system attacks the body. It can cause lasting damage to different body parts, especially the kidneys, called Lupus Nephritis (LN). This study checks if a new cell therapy, CABA-201, is safe and works well. Patients with active SLE (either with or without kidney issues) can try this treatment. They will receive one dose of CABA-201 after getting other medicines called Cyclophosphamide (CY) and Fludarabine (FLU) to prepare their bodies.

  • Participants need to be between 18 and 65 years old.
  • They must have an SLE diagnosis with specific antibodies, and for LN patients, a proven kidney condition.
  • This study involves checking for any severe health issues that could make it unsafe for you.

If you've had a severe reaction to similar medicines, have an active infection, or received certain transplants, you cannot join. It's important to talk with your doctor to see if this study is right for you.

Study details
    Systemic Lupus Erythematosus
    Lupus Nephritis

NCT06121297

Cabaletta Bio

16 March 2025

Step 1 Get in touch with the nearest study center
Entire USA
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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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