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


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Trial ID: NCT05168202


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

Stanford Investigator(s)

Gabriel Mannis
Gabriel Mannis

Associate Professor of Medicine (Hematology)


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

   - 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


drug: CC-95251

drug: Azacitidine

drug: Venetoclax


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ji Hyun Choi
+1 650-723-1367

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