Engineered immune cells take on lupus and scleroderma in early trial

NCT ID NCT07038447

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new treatment called KITE-363 for people with severe autoimmune diseases like lupus and scleroderma that haven't improved with standard treatments. KITE-363 is a type of cell therapy where a patient's own immune cells are modified in a lab to target and attack faulty immune cells. The study will enroll 52 participants and aims to find a safe dose and see if the therapy can reduce disease activity.

What this could mean

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

Active substance
KITE-363 (a CAR T-cell therapy targeting CD19 and CD20)
What this could lead to
If successful, this could point toward a new treatment option for people with severe autoimmune diseases that haven't responded to standard therapies.
What could go wrong
This is an early phase 1 trial with only 52 participants, so safety and effectiveness are not yet proven. There are risks of serious side effects from the chemotherapy and the cell therapy itself.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Concord Repatriation General Hospital

    Syndey, New South Wales, 2139, Australia

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Jewish General Hospital

    Montreal, H3T1E2, Canada

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065, Australia

  • Stanford University

    Stanford, California, 94305, United States

  • Tampa General Hospital Cancer Institute

    Tampa, Florida, 33606, United States

  • The Ottawa Hospital, General Campus

    Ottawa, K1H 8L6, Canada

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