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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA059-001  |   NCT05168202

A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes

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Summary

  • Phase 1
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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.

Key Eligibility Criteria

Inclusion Criteria: • 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) Exclusion Criteria: - 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: CC-95251 + azacitidine

ASSIGNED INTERVENTION
  • Drug: CC-95251, Azacitidine

Study Arms

Experimental: CC-95251 + azacitidine + venetoclax

ASSIGNED INTERVENTION
  • Drug: Venetoclax

Study Arms

Experimental: CC-95251 monotherapy

ASSIGNED INTERVENTION
  • Drug: CC-95251