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A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis

Comparing Zola-cel therapy to standard care for systemic sclerosis.

Recruiting
16 years and older
All
Phase 3

This study is researching a treatment called BMS-986353 (also known as Zolacabtagene-Autoleucel or Zola-cel) for people with a condition called Systemic Sclerosis (SSc). SSc is a disease that causes thickening and hardening of the skin. Some SSc patients also have Interstitial Lung Disease (ILD), which affects the lungs.

Participants in this study will either continue their usual treatment or receive the new treatment if their condition worsens. To join, participants must meet certain conditions, like having specific antibodies in their blood and lung disease confirmed by a special scan. They must also have tried other medicines for at least 6 months without success.

Some people cannot participate, like those needing oxygen therapy or with other serious lung problems. The study aims to see if the new treatment is better and safer than the current standard care.

  • The study involves comparing new treatment with current treatment.
  • Participants may switch to new treatment if their condition worsens.
  • Participants must meet specific health criteria to join.
Study details
    Systemic Sclerosis

NCT07335562

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

16 May 2026

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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.

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