anzurstobart (BMS-986351) / BMS - LARVOL DELTA

A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed | N=218 ➔ 56 | Trial completion date: Jun 2026 ➔ Jul 2024 | Trial primary completion date: Jun 2026 ➔ Jul 2024

Combination therapy • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

CC-95251-ST-001: A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers (clinicaltrials.gov) - P1 | N=206 | Terminated | Sponsor: Celgene | Active, not recruiting ➔ Terminated; Business objectives have changed.

Combination therapy • Metastases • Trial termination • Colorectal Cancer • Follicular Lymphoma • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Disorders • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Squamous Cell Carcinoma of Head and Neck • CD20

A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes (clinicaltrials.gov) - P1 | N=218 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Discovery and Preclinical Activity of BMS-986351, an Antibody to SIRPα that Enhances Macrophage-Mediated Tumor Phagocytosis when Combined with Opsonizing Antibodies. (PubMed, Cancer Res Commun) - P1 | "In vitro, BMS-986351 increased phagocytic activity against cell lines from solid tumors and hematological malignancies, and this effect was markedly enhanced when BMS-986351 was combined with the opsonizing antibodies cetuximab and rituximab. A phase I dose escalation/ expansion study of BMS-986351 for the treatment of advanced solid and hematologic malignancies is underway (NCT03783403)."

Journal • Preclinical • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor • CD47 • SIRPA

CC-95251-ST-001: A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers (clinicaltrials.gov) - P1 | N=230 | Active, not recruiting | Sponsor: Celgene | Trial completion date: Aug 2025 ➔ Aug 2024

Combination therapy • Metastases • Trial completion date • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Disorders • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Squamous Cell Carcinoma of Head and Neck • CD20

A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes (clinicaltrials.gov) - P1 | N=218 | Recruiting | Sponsor: Bristol-Myers Squibb | N=30 ➔ 218

Combination therapy • Enrollment change • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

CC-95251-ST-001: A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers (clinicaltrials.gov) - P1 | N=230 | Active, not recruiting | Sponsor: Celgene | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Colorectal Cancer • Follicular Lymphoma • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Disorders • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD20

Discovery and Preclinical Characterization of CC-95251, an Anti-SIRPα Antibody That Enhances Macrophage-Mediated Phagocytosis of Non-Hodgkin Lymphoma (NHL) Cells When Combined with Rituximab (ASH 2021) - P1 | "These results support the clinical evaluation of CC-95251 + rituximab for relapsed or refractory NHL. A phase 1 dose-escalation and -expansion study of CC-95251 for the treatment of advanced solid and hematologic malignancies is underway (NCT03783403)."

Preclinical • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD163 • CD20 • CD47 • SIRPA

FIRST CLINICAL STUDY OF THE ANTI-SIGNAL REGULATORY PROTEIN-ALPHA (SIRPΑ) ANTIBODY CC-95251 COMBINED WITH RITUXIMAB IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) NON-HODGKIN LYMPHOMA (NHL) (EHA 2022) - P1 | "Conclusion CC-95251 + ritux demonstrated a manageable safety profile and promising efficacy in pts with heavily pretreated CD20+ R/R NHL. The study is currently enrolling in the dose-expansion phase."

Clinical • Anemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • CD47 • SIRPA

Interim Results from the First Clinical Study of CC-95251, an Anti-Signal Regulatory Protein-Alpha (SIRPα) Antibody, in Combination with Rituximab in Patients with Relapsed and/or Refractory Non-Hodgkin Lymphoma (R/R NHL) (ASH 2021) - P1 | " CC-95251-ST-001 (NCT03783403) is a multicenter, open-label, phase 1, dose-escalation and expansion study of CC-95251 in pts with advanced solid tumors and CD20+ R/R NHL. CC-95251, a novel anti-SIRPα antibody, demonstrated a manageable safety profile and promising efficacy in combination with rituximab in pts with heavily pretreated CD20+ R/R NHL. The study continues to enroll in the dose-expansion phase. Updated safety and efficacy data will be presented."

Clinical • Combination therapy • Anemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CD20 • CD47 • SIRPA

CC-95251-ST-001: A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers (clinicaltrials.gov) - P1 | N=230 | Recruiting | Sponsor: Celgene | Trial completion date: Nov 2024 ➔ Aug 2025 | Trial primary completion date: Nov 2022 ➔ Jun 2024

Combination therapy • Trial completion date • Trial primary completion date • Follicular Lymphoma • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD20

A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting | N=166 ➔ 30 | Trial completion date: Sep 2027 ➔ Jun 2026

Combination therapy • Enrollment change • Enrollment open • Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes (clinicaltrials.gov) - P1; N=166; Not yet recruiting; Sponsor: Bristol-Myers Squibb

Clinical • Combination therapy • New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Bristol Myers Squibb to Highlight More than 80 Abstracts at ASH 2021 Demonstrating Strength of Innovative Therapeutic Platforms Improving Outcomes for a Broad Range of Hematologic Diseases (Businesswire) - "Bristol Myers Squibb...today announced the presentation of research across a wide range of hematologic diseases at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, which will take place in Atlanta, Georgia, and virtually, from December 11 to 14, 2021. Data from more than 80 company-sponsored studies will be featured, including 23 oral presentations, highlighting key research and development programs in lymphomas, leukemias, multiple myeloma and myeloid diseases, and showcasing our commitment to delivering transformative medicines across major hematologic diseases."

P1 data • P2 data • P3 data • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology

A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Subjects With Advanced Solid and Hematologic Cancers (clinicaltrials.gov) - P1; N=230; Recruiting; Sponsor: Celgene; Trial completion date: Jan 2023 ➔ Dec 2024

Trial completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology