Engineered immune cells take on rare autoimmune disease

NCT ID NCT07298590

Not yet recruiting Disease control Sponsor: Changhai Hospital Source: ClinicalTrials.gov ↗

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

Summary

This early-phase study tests a new treatment called KN5601, which uses specially engineered natural killer (NK) cells to target and destroy disease-causing immune cells in people with relapsed or refractory IgG4-related disease. The trial will enroll 18 adults and primarily check for safety and whether the disease goes into remission without needing steroids.

What this could mean

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

Active substance: CD19/BCMA CAR-NK cells (KN5601) with chemotherapy (fludarabine and cyclophosphamide)
What this could lead to: If successful, this could point toward a new treatment option for people with hard-to-treat IgG4-related disease, potentially reducing symptoms without long-term steroids.
What could go wrong: This is a very early, small trial (18 people) focused on safety. The treatment involves chemotherapy and cell therapy, which can cause serious side effects. It may not work or may not be better than existing treatments.

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Conditions

The condition(s) this trial relates to.

Immunoglobulin G4-Related Disease immunoglobulin G4-related sclerosing disease

As listed by the trial registrant

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

IGG4-RELATED DISEASE

Contacts and locations

Locations

Changhai Hospital

Shanghai, 200433, China

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Other studies related to the condition(s) this trial covers.