Open Actively Recruiting
A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
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.
- 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 (ie, previously untreated) MDS as defined by the 2016 WHO Classification with intermediate, high or very high risk by IPSS-R
- 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
Join this Trial
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- UCLA Westwood
For detailed technical eligibility, visit ClinicalTrials.gov.