Immune system overhaul: could CAR T-Cells tame autoimmune disease?

NCT ID NCT06152172

Ongoing Disease control Sponsor: David Porter Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing a new treatment called KYV-101 for people with severe autoimmune diseases like lupus, scleroderma, and vasculitis. The treatment involves taking a patient's own immune cells, modifying them to target and destroy faulty B cells, and giving them back as a one-time infusion. The main goal is to see if it is safe and tolerable, with a small group of 24 participants being followed for two years.

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 CAR T-cell therapy made from the patient's own immune cells)
What this could lead to: If successful, this could point toward a new treatment option for people with severe autoimmune diseases that are not controlled by current therapies.
What could go wrong: This is a very early Phase 1 trial with only 24 participants, so it is too soon to know if it works. There are also risks from the chemotherapy given beforehand and potential side effects from the cell therapy.

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy anti-neutrophil cytoplasmic antibody-associated vasculitis antisynthetase syndrome dermatomyositis diffuse cutaneous systemic sclerosis diffuse scleroderma granulomatosis with polyangiitis idiopathic inflammatory myopathy immune-mediated necrotizing myopathy lupus nephritis myositis disease polymyositis

As listed by the trial registrant

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

ANCA-ASSOCIATED VASCULITIS DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS IDIOPATHIC INFLAMMATORY MYOPATHIES SLE NEPHRITIS

Contacts and locations

Locations

Hospital of the Universithy of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

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