High-risk large B-cell lymphoma includes large B-cell lymphoma with International Prognostic Index (IPI) score ≥3, and high-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 translocations (double-/triple-hit lymphomas; DHL/THL). Patients with high-risk large B-cell lymphoma (IPI≥3) have a low response to standard first-line chemotherapy, with complete response rate (CRR) 47.3%, 3-year overall survival (OS) rate 58.9% and progression-free survival (PFS) rate 40.7%. HGBL patients with MYC and BCL2 and/or BCL6 translocations (DHL/THL) tend to have poor prognostic indicators (e.g. bone marrow involvement, central nervous system (CNS) involvement, and elevated lactate dehydrogenase) and no recommended standard first-line therapies, with poor efficacy (CRR 59.6%) to traditional standard first-line R-CHOP chemotherapy. CRR of these patients remains <60% when treated with DA-EPOCH-R therapy and there is no significant survival benefit with the more aggressive induction regimen compared with standard R-CHOP. Therefore, there are substantial unmet clinical needs in the first-line treatment of high-risk large B-cell lymphoma patients, and new treatment options are urgently needed.

In its pivotal clinical study (RELIANCE study), Carteyva^® has demonstrated manageable safety profiles and high efficacy in patients with relapsed/refractory large B-cell lymphoma who have received at least two lines of therapies. The encouraging results have inspired CAR-T therapy destined for earlier lines of therapies in high-risk large B-cell lymphoma.

The study is an open-label, single-arm, multicenter, and investigator-initiated trial (IIT) in China, aiming to evaluate the efficacy and safety of Carteyva^® as first-line therapy in adult subjects with high-risk large B-cell lymphoma.