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Imlifidase

Kidney transplantation in highly sensitized patients

Manufacturer
Hansa Biopharma
Regulatory submission
BLA submitted December 2025
Last updated
85 sources

Clinical evidence

Anti-MICA antibody case report

8 evidence topics · 1 source

Objective
Location and study date

No evidence found.

Study design
Eligibility criteria

Not applicable.

Treatment
Study outcomes
Rationale for using Anti-MICA antibody reduction as the primary endpoint

Not applicable.

Statistical analysis description
Number of participants (Planned and analyzed)
Description of analysis sets

Not applicable.

Results
Participant disposition

No evidence found.

Baseline characteristics
Efficacy results
Antibody rebound and subsequent removal
OutcomeQuoted timing
Anti-MICA donor-specific antibody rebound after imlifidase“14 days”
Removal of anti-MICA antibodies after subsequent treatment“day 45”
Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results
Study limitations
Summary

This report describes one recipient with preformed anti-MICA donor-specific antibodies. Antibody rebound occurred after 14 days, and early antibody-mediated rejection was reported. Later antibody removal followed immunoadsorption and daratumumab, so that outcome cannot be attributed to imlifidase alone.