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

Purpose

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)

Eligibility


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

Intervention(s):

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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