GC Cell, a Korean contract development and manufacturing organization (CDMO) for cell and gene therapies, said Wednesday that it has received approval from the Ministry of Food and Drug Safety (MFDS) for its investigational new drug (IND) application submitted in May. The application was for a phase 1 clinical trial of its T-cell lymphoma treatment candidate, GCC2005.

GC Cell has received IND approval for GCC2005, an allogeneic CAR-NK cell therapy targeting CD5 in T-cell lymphoma. 
GC Cell has received IND approval for GCC2005, an allogeneic CAR-NK cell therapy targeting CD5 in T-cell lymphoma. 

GCC2005, an allogeneic cell therapy derived from umbilical cord blood (UCB), utilizes natural killer (NK) cells to target the CD5 marker, a protein highly expressed on the surface of various T-cell lymphoma subtypes. According to GC Cell, GCC2005 is poised to provide therapeutic options across these diverse subtypes.

T-cell lymphoma is a type of lymphoma that occurs in lymphoid tissues outside of lymph nodes, affecting NK cells and T-cells. It is relatively more common in Asian countries, including Korea, than in the U.S. or Europe.

This condition is broadly categorized into cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL), with PTCL being further classified into about 36 different subtypes. PTCL generally has a poorer prognosis compared to B-cell lymphomas and is known for its high unmet medical need due to limited treatment options.

GCC2005 is a CAR-NK cell therapy that co-expresses chimeric antigen receptors (CAR) and IL-15, enhancing the persistence and efficacy of NK cells. The therapy also benefits from GC Cell's large-scale production and cryopreservation platform, offering a cost-effective, off-the-shelf treatment compared to autologous CAR-T therapies, GC Cell said. Existing CAR-T therapies face challenges such as fratricide, malignant CAR-T generation, and prolonged T-cell aplasia, which GCC2005 is expected to overcome.

Following the IND approval, GC Cell plans to initiate a phase 1 clinical trial by the end of the year. The trial will evaluate the safety, tolerability, and preliminary efficacy of GCC2005 in combination with lymphodepleting chemotherapy in patients with relapsed or refractory T-cell malignancies, in collaboration with approximately six research institutions.

Copyright © KBR Unauthorized reproduction, redistribution prohibited