China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its CAR-T-19-D2 (CAR-T-19-DNR or RC19D2) in recurrent/refractory diffuse large B-cell lymphoma (DLBCL).
Mechanism of Action and Clinical Need
CAR-T-19-D2 targets the CD19 molecule, guiding autoimmune cells to recognize the protein on immune cells and inhibit tumor growth. This therapy addresses a significant unmet medical need, as approximately 65% to 75% of newly diagnosed DLBCL patients achieve complete remission (CR) after first-line treatment. However, the three-year median progression-free survival (PFS) after hematopoietic stem cell transplantation for patients with recurrent/refractory DLBCL is only 35%.
Significance of CD19 Targeting
The CD19 molecule is a surface marker specific to B cells, and DLBCL is a tumor of B cell origin. This makes CAR-T cell therapies targeting the CD19 molecule a valuable salvage therapy for r/r DLBCL in clinical practice. The approval of CAR-T-19-D2 for clinical trials marks a significant step forward in the development of innovative treatments for this challenging form of lymphoma.-Fineline Info & Tech
