The agent has also previously earned FDA rare pediatric disease designation and regenerative medicine advanced therapy designation in the same indication.1About TENACITY-01 and Preliminary DataThe ongoing single-arm, open-label TENACITY-01 study is spearheading the clinical development of CTD402. The trial aims to enroll a total of 54 patients across sites in the United States, European Union, and Asia. Imviva Biotech receives FDA orphan drug designation for CTD402 for the treatment of T-cell leukemia and lymphoma. A study of CTD402 in T-ALL/LBL patients (TENACITY-01). CTD402, allogeneic anti-CD7 CAR t-cell, in relapsed or refractory (R/R) t-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) - report of clinical outcomes at the recommended phase 2 dose (RP2D).