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Experimental CAR-T therapy takes aim at Hard-to-Treat scleroderma

NCT ID NCT06400303

First seen Nov 01, 2025 · Last updated Jun 23, 2026 · Updated 29 times

Summary

This early-phase trial is testing a new treatment called KYV-101 for people with systemic sclerosis, a disease where the immune system attacks the body, causing skin and organ damage. The therapy uses a patient's own modified immune cells to target and destroy certain B cells that may drive the disease. Only 3 participants are enrolled, and the main goals are to check safety and see if the treatment can improve symptoms.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • Northwell Health

    Great Neck, New York, 11021, United States

  • Stanford University Medical Center

    Palo Alto, California, 94305, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

KYV-101 (a type of CAR-T cell therapy made from the patient's own immune cells, designed to target and destroy B cells)

What this could lead to

If successful, this could point toward a new treatment option for systemic sclerosis that targets the immune system's role in the disease.

What could go wrong

This is a very early, small trial with only 3 participants, so results may not apply to everyone. CAR-T therapy can cause serious side effects like cytokine release syndrome and infections.

Conditions

The condition(s) this trial relates to.

autoimmune disease diffuse scleroderma systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.