GcCell, 'CD5 CAR-NK' T Cell Lymphoma Domestic Phase 1 Clinical Trial IND Approval

GC Cell announced on the 14th that it received approval for the Phase 1 clinical trial application (IND) for ‘GCC2005 (CD5 CAR-NK)’, a T-Cell Lymphoma treatment candidate submitted to the Ministry of Food and Drug Safety in May.

GCC2005 is an allogeneic cell therapy made from umbilical cord blood-derived NK cells. It targets the CD5 marker, which is highly expressed in T-Cell Lymphoma. CD5 shows high expression in many subtypes of T-Cell Lymphoma, and it is expected to provide a treatment option for various lymphoma subtypes.

T-Cell Lymphoma is a lymphoma of the NK cell and T cell lineages that occurs in lymphoid tissues other than lymph nodes. It is relatively more common in Asian countries including Korea than in the United States and Europe. It is broadly divided into Cutaneous T-Cell Lymphoma (CTCL) and Peripheral T-Cell Lymphoma (PTCL). Peripheral T-Cell Lymphoma can be classified into about 36 different subtypes. PTCL generally has a poorer prognosis compared to B-cell lymphoma. It is known as a rare and intractable disease with high unmet medical needs due to the lack of treatment options.

GCC2005 is a CAR NK cell therapy that co-expresses CAR and IL-15 to improve the short persistence of conventional NK cells and enhance efficacy. Through GC Cell’s mass production and cryopreservation platform, it has higher cost competitiveness compared to autologous CAR-T therapies. Existing CAR-T therapies can cause issues such as fratricide, where CAR-T cells expressing CD5 kill each other, malignant CAR-T generation, and persistent in vivo T-Cell Aplasia. GCC2005 is expected to overcome these limitations of CAR-T therapies.

In April, the American Association for Cancer Research (AACR) presented the nonclinical efficacy evaluation results of GCC2005. It attracted significant industry attention by demonstrating excellent cancer cell killing ability and improved in vivo persistence, showing potential as an innovative new drug for T-Cell Lymphoma.

After IND approval, GC Cell plans to sign contracts with about six research institutions and initiate a Phase 1 clinical trial within this year to evaluate safety, tolerability, and preliminary efficacy in combination with lymphodepleting chemotherapy in patients with relapsed or refractory T-cell malignancies after patient recruitment.