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Korea clears a CAR-NK therapy for one refractory lymphoma patient

Diagram of CD5 CAR-NK cell manufacturing showing a blood sample yielding an NK cell that is expanded with a feeder cell into activated NK cells, then transduced with virus to become antibody-studded CAR-NK cells.

Lin et al., Journal of Translational Medicine 2025 (CC BY 4.0)CC BY

South Korea’s Ministry of Food and Drug Safety approved compassionate use of GCC2005 on 18 September 2026, on an application filed by Seoul National University Hospital for a patient with refractory peripheral T-cell lymphoma who had exhausted standard chemotherapy.

GCC2005 is an allogeneic CAR-NK cell therapy aimed at CD5. Two things in that sentence matter. Allogeneic means the cells come from a donor and are manufactured in advance, rather than being made from each patient’s own cells over weeks — the delay that patients with fast-moving disease frequently do not survive. And natural killer cells, rather than T cells, are the chassis: targeting CD5 with engineered T cells is awkward, because CD5 sits on T cells themselves, so the therapy attacks its own kind.

Compassionate use is not approval. It is a regulator permitting one named patient to receive an unapproved drug because nothing else is left, and it carries no claim that the therapy works. GC Cell has finished dosing the Phase 1a portion in Korea and says it is preparing Phase 1b. Professor Byun Ja-min of Seoul National University Hospital, the domestic Phase 1 investigator, is leading the treatment.

Sources

  1. [1]GC Cell Wins Approval for Compassionate Use of CD5 CAR-NK TherapySeoul Economic Daily··Article