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MK-1045

BIOLOGICAL10 trials

Sponsors

Merck Sharp & Dohme LLC, MSD R&D (China) Co., Ltd.

Conditions

Acute Lymphoblastic LeukemiaB-cell Acute Lymphoblastic LeukemiaChronic Lymphocytic LeukaemiaFollicular LymphomaHematologic MalignanciesLymphoma, FollicularLymphoma, Large B-Cell, DiffuseLymphoma, Non-Hodgkin

Phase 1

A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)
RecruitingNCT05579132
MSD R&D (China) Co., Ltd.Acute Lymphoblastic Leukemia
Start: 2022-11-01End: 2028-06-30Target: 203Updated: 2026-07-13
A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)
RecruitingNCT06189391
MSD R&D (China) Co., Ltd.Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Start: 2021-03-16End: 2029-03-30Target: 100Updated: 2026-06-26
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
RecruitingNCT07363590
Merck Sharp & Dohme LLCRheumatoid Arthritis, Systemic Lupus Erythematosus
Start: 2026-02-19End: 2029-07-16Target: 21Updated: 2026-06-23
A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
RecruitingNCT07519772
Merck Sharp & Dohme LLCLymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
Start: 2026-05-03End: 2031-04-01Target: 200Updated: 2026-07-17
A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK‑1045 Monotherapy or in Combination with Other Anticancer Agents in Participants with Non-Hodgkin Lymphoma
Not yet recruitingCTIS2025-523005-15-00
Merck Sharp & Dohme LLCNon-Hodgkin Lymphoma
Target: 58Updated: 2026-05-29

Phase 2

A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
RecruitingNCT07570173
Merck Sharp & Dohme LLCB-cell Acute Lymphoblastic Leukemia
Start: 2026-05-18End: 2033-10-18Target: 340Updated: 2026-07-17
A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
RecruitingNCT07634471
Merck Sharp & Dohme LLCFollicular Lymphoma
Start: 2026-06-22End: 2035-07-23Target: 960Updated: 2026-07-10
A Phase 2/3 randomized, open-label study of MK-1045 in combination with rituximab in patients with 1L follicular lymphoma.
Not yet recruitingCTIS2025-522777-10-00
Merck Sharp & Dohme LLCFollicular Lymphoma
Target: 2Updated: 2026-06-09
A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Not yet recruitingCTIS2025-522267-15-00
Merck Sharp & Dohme LLC​Relapsed/refractory B-cell Acute Lymphoblastic Leukemia​
Target: 36Updated: 2026-06-12
A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)
Not yet recruitingNCT07709000
Merck Sharp & Dohme LLCChronic Lymphocytic Leukaemia, Hematologic Malignancies, Small Lymphocytic Lymphoma
Start: 2026-08-21End: 2033-11-16Target: 60Updated: 2026-07-16

Related Papers

Abstract 1625: VHH nanobody-masked conditionally active CDH17 T cell engager for colorectal cancer
Cancer Research2026-04-03
Updated results from the Phase 1b/2 study of MK-1045, a novel CD19xCD3 T-cell engager, in adult participants with relapsed or refractory B-cell acute lymphoblastic leukemia
Blood2025-11-03
Phase 1 study of MK-1045, a novel CD19xCD3 T-cell engager, in participants with relapsed or refractory diffuse large B-cell lymphoma
Blood2025-11-03
Phase 1 study of MK-1045, a novel CD19xCD3 T-cell engager, in participants with relapsed or refractory follicular lymphoma
Blood2025-11-03
Phase I study of CN201, a novel CD3xCD19 IgG4 bispecific antibody, in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
Journal of Clinical Oncology2024-06-012 citations
Phase I study of CN201, a novel CD3xCD19 bispecific antibody, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.
Journal of Clinical Oncology2024-06-01