AZD5492 / AstraZeneca - LARVOL DELTA

TITANium: An open-label, global multicenter phase 1/2 study of AZD5492, a first-in-class subcutaneous CD8-guided tri-specific T-cell engager (TCE), in patients (pts) with relapsed or refractory (r/r) B-cell malignancies. (ASCO 2025) - P1/2 | "Key secondary objectives are to evaluate preliminary efficacy, pharmacokinetics and immunogenicity of AZD5492. Enrollment began in September 2024 and is currently ongoing."

Clinical • P1/2 data • Trispecific • B Cell Lymphoma • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • CD20 • CD4 • CD8

TITANIUM: AN OPEN-LABEL, MULTICENTER PHASE 1/2 STUDY OF AZD5492, A FIRST-IN-CLASS SUBCUTANEOUS CD8-GUIDED TRISPECIFIC T-CELL ENGAGER, IN PATIENTS WITH RELAPSED OR REFRACTORY B-CELL MALIGNANCIES (EHA 2025) - P1/2 | "Reused with permission. This abstract was accepted and previously presented at the 2025 ASCO Annual Meeting."

Clinical • P1/2 data • Trispecific • B Cell Lymphoma • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • CD20 • CD4 • CD8

TITANium: A multicenter Phase 1/2 study of AZD5492, a first-in-class CD8-guided trispecific T-cell engager, in patients with relapsed/refractory B-cell malignancies (ICML 2025) - No abstract available

Clinical • P1/2 data • Trispecific • Hematological Malignancies • Lymphoma • Oncology

TITAN: A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: AstraZeneca

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Myositis • Systemic Lupus Erythematosus

Pre-Clinical Evaluation of AZD5492, a Novel CD8-Guided T Cell Engager, for B-Non Hodgkin Lymphoma Indications (ASH 2024) - "AZD5492 has therefore the potential to significantly improve therapeutic index. AZD5492 IND has been approved by the FDA and a FIH study in patients with R/R NHL and CLL is ongoing."

Preclinical • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD4 • CD8

AstraZeneca showcases strength of haematology portfolio and pipeline at ASH 2024 (AstraZeneca Press Release) - P1/2 | N=20 | NCT04935580 | Sponsor: Shanghai Changzheng Hospital | "Early data for AZD0120 (GC012F)...will show potential as a first-line therapy for elderly patients with newly diagnosed transplant ineligible MM. Preliminary results from the ongoing investigator-initiated trial of AZD0120 suggest deep responses and an acceptable safety profile, with no ICANS and no ≥Grade 2 CRS events observed in this patient population. An oral presentation will share preclinical data demonstrating the anti-tumour activity of AZD5492, a next-generation CD8 selective, CD20-targeting T-cell engager, designed using AstraZeneca’s innovative Target Induced T-cell Activating Nanobody (TITAN) platform."

P1/2 data • Preclinical • Multiple Myeloma • Oncology

Development of TITAN: a new CD8-guided T cell engager platform for hematological and solid tumor applications (SITC 2024) - "AZD5492, a CD20-targeting TITAN is currently being developed for B-NHL and CLL indication. Ethics Approval The in vivo studies were conducted according to Institutional Animal Care and Use Committee approved protocols in the Laboratory Animal Resources facility at AstraZeneca, an Association for Animal Accreditation of Laboratory Animal Care and United States Department of Agriculture-licensed facility. Human PBMCs were used in accordance with Informed Consent Forms (ICF)."

Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lung Cancer • Oncology • Solid Tumor • CD4 • CD8

TITANium: A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies. (clinicaltrials.gov) - P1/2 | N=174 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Oncology

AstraZeneca (AZN.US) has applied for clinical trials in China for a trispecific antibody for the treatment of type B non-Hodgkin's lymphoma [Google translation] (Zhitong Finance) - "Zhitong Finance APP learned that on August 17, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that AstraZeneca ( AZN.US )'s AZD5492 was submitted for clinical trials in China and was accepted....AstraZeneca has registered a Phase 1/2 clinical study to evaluate the safety, PK, PD and efficacy of AZD5492 in patients with relapsed/refractory B-cell malignancies. The study is planned to be conducted in 19 centers in the United States, Australia, etc., with a planned enrollment of 174 subjects, and is expected to end in February 2028."

Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

TITANium: A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies. (clinicaltrials.gov) - P1/2 | N=174 | Not yet recruiting | Sponsor: AstraZeneca

New P1/2 trial • Hematological Malignancies • Oncology