for people ages 18 years and up (full criteria)
study started
completion around



The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 alone and in combination with antineoplastic agents in participants with relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive higher risk melodysplastic syndromes.

Official Title

A Phase 1, Open-label, Dose Finding Study of CC-95251 Alone and in Combination With Antineoplastic Agents in Subjects With Acute Myeloid Leukemia and Myelodysplastic Syndromes


Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Acute Myeloid Leukemia, AML, MDS, Hematologic Cancers, Leukemia, Anti-SIRPa antibody, CC-95251, Myeloid Leukemia, Preleukemia, Syndrome, Azacitidine, Venetoclax, CC-95251 monotherapy, CC-95251 + azacitidine, CC-95251 + azacitidine + venetoclax


You can join if…

Open to people ages 18 years and up

• Eastern Cooperative Oncology Group Performance Status of 0 to 2

For Parts A & B:

  • Relapsed or refractory (R/R) acute myeloid leukemia (AML) as defined by the 2016 WHO Classification
  • R/R myelodysplastic syndromes (MDS) as defined by the 2016 WHO Classification with intermediate, high or very high risk by Revised International Prognostic Scoring System (IPSS-R)

For Part C:

• Treatment-naïve (TN) (ie, previously untreated) MDS as defined by the 2016 WHO Classification with intermediate, high or very high risk by IPSS-R

For Part D:

• TN AML as defined by the 2016 WHO Classification, including secondary AML and therapy-related AML in participants who are ineligible (IE) for intensive chemotherapy (IC) and allogeneic hematopoietic stem cell transplant (HSCT)

You CAN'T join if...

  • Acute promyelocytic leukemia
  • Immediately life-threatening, severe complications of leukemia such as disseminated/uncontrolled infection, uncontrolled bleeding, and/or uncontrolled disseminated intravascular coagulation
  • Participants who have received prior treatment with a CD47 or SIRPα targeting agent
  • Participant is on chronic systemic immunosuppressive therapy or corticosteroids
  • Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting study treatment, whichever is shorter (relapsed or refractory participants only).
  • Any condition including, active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study
  • Pregnant or nursing participants.

Other protocol-defined inclusion/exclusion criteria apply


  • Local Institution - 0030
    Los Angeles California 90095 United States
  • Local Institution - 0031
    Palo Alto California 94304 United States


in progress, not accepting new patients
Start Date
Completion Date
Bristol-Myers Squibb
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
Phase 1 research study
Study Type
Expecting 218 study participants
Last Updated