MK-1045
/ Merck (MSD), Curon Biopharma
- LARVOL DELTA
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April 25, 2024
Phase I study of CN201, a novel CD3xCD19 IgG4 bispecific antibody, in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
(ASCO 2024)
- P1/2 | "Preliminary data show CN201 has a well tolerable safety profile and promising activity in adult patients with relapsed or refractory ALL."
Clinical • P1 data • Acute Lymphocytic Leukemia • Anemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Leukemia • Leukopenia • Neutropenia • Oncology • Thrombocytopenia
August 21, 2026
CN201-103: A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)
(clinicaltrials.gov)
- P1/2 | N=203 | Recruiting | Sponsor: MSD R&D (China) Co., Ltd. | Trial completion date: Jun 2028 ➔ Dec 2028 | Trial primary completion date: Jun 2028 ➔ Dec 2028
Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology
August 08, 2026
A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
(clinicaltrials.gov)
- P1/2 | N=280 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=200 ➔ 280
Enrollment change • Monotherapy • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
July 17, 2026
A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)
(clinicaltrials.gov)
- P2 | N=60 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC
New P2 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma
November 04, 2025
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
(ASH 2025)
- P1/2 | "Introduction: MK-1045 (CN201) is a humanized bispecific IgG4 CD19xCD3 T-cell engager that has shownencouraging safety, tolerability, and preliminary efficacy in participants with relapsed or refractory (R/R)B-cell acute lymphoblastic leukemia (B-ALL) (Wang et al...Among participants withprior exposure to blinatumomab or CAR T-cell therapy who had received a target dose ≥60 mg, 5 of 5participants achieved CR/CRi/CRh and 4 achieved MRD negativity... The safety profile of MK-1045 in adult participants with R/R B-ALL has been generallymanageable with dose modifications and standard medical care. MK-1045 has shown encouraging singleagent antitumor activity in adult participants with R/R B-ALL, achieving a CR/CRi/CRh rate of 92% at the2/20/90 mg dose level."
Clinical • P1/2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia
June 23, 2026
A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
(clinicaltrials.gov)
- P2/3 | N=960 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting
Enrollment open • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CD20
June 23, 2026
A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
(clinicaltrials.gov)
- P1/2 | N=200 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Oct 2030 ➔ Apr 2031 | Trial primary completion date: Jan 2030 ➔ Jul 2030
Monotherapy • Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
June 15, 2026
MK-1045-005: A clinical trial of MK-1045 in people with B-cell acute lymphoblastic leukemia
(clinicaltrialsregister.eu)
- P2/3 | N=36 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC
New P2/3 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology
June 09, 2026
A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
(clinicaltrials.gov)
- P2/3 | N=960 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC
New P2/3 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CD20
June 11, 2026
A clinical trial of MK-1045 and rituximab in people with follicular lymphoma (MK-1045-007)
(clinicaltrialsregister.eu)
- P2/3 | N=2 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC
New P2/3 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CD20
June 06, 2026
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
(clinicaltrials.gov)
- P2/3 | N=340 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Oct 2029 ➔ Oct 2033 | Trial primary completion date: Feb 2029 ➔ Oct 2033
Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology
June 01, 2026
A clinical study of MK-1045 in people with non-Hodgkin lymphoma (MK-1045-008)
(clinicaltrialsregister.eu)
- P1/2 | N=58 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC
Monotherapy • New P1/2 trial • B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
May 12, 2026
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
(clinicaltrials.gov)
- P2/3 | N=340 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting
Enrollment open • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology
May 07, 2026
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
(clinicaltrials.gov)
- P2/3 | N=340 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC
New P2/3 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology
May 16, 2026
A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
(clinicaltrials.gov)
- P1/2 | N=200 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting
Enrollment open • Monotherapy • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
May 04, 2026
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
(clinicaltrials.gov)
- P1 | N=21 | Recruiting | Sponsor: Merck Sharp & Dohme LLC
Trial initiation date • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus
April 21, 2026
Updated Phase 1b/2 Results: MK-1045 in Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
(BSH 2026)
- No abstract available
P1/2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia
April 10, 2026
A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
(clinicaltrials.gov)
- P1/2 | N=200 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC
Monotherapy • New P1/2 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
April 02, 2026
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
(clinicaltrials.gov)
- P1 | N=21 | Recruiting | Sponsor: Merck Sharp & Dohme LLC
Trial initiation date • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus
March 20, 2026
A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)
(clinicaltrials.gov)
- P1 | N=100 | Recruiting | Sponsor: MSD R&D (China) Co., Ltd. | Trial primary completion date: Mar 2027 ➔ Sep 2028
Trial primary completion date • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL2
February 23, 2026
A clinical study of MK-1045 in people with lupus or rheumatoid arthritis (MK-1045-004)
(clinicaltrialsregister.eu)
- P1 | N=11 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting
Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus
February 18, 2026
A clinical study of MK-1045 in people with lupus or rheumatoid arthritis (MK-1045-004)
(clinicaltrialsregister.eu)
- P1 | N=11 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC
New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus
February 21, 2026
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
(clinicaltrials.gov)
- P1 | N=21 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting
Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus
February 14, 2026
CN201-103: A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)
(clinicaltrials.gov)
- P1/2 | N=203 | Recruiting | Sponsor: MSD R&D (China) Co., Ltd. | Trial completion date: Jan 2027 ➔ Jun 2028 | Trial primary completion date: Jan 2027 ➔ Jun 2028
Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology
January 24, 2026
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
(clinicaltrials.gov)
- P1 | N=21 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC
New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus
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