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

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 1

Conditions: Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Treatments: Drug: Venetoclax; Drug: CC-95251; Drug: Azacitidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05168202

CA059-001

2021-002799-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 218 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 3 patient groups

CC-95251 monotherapy

Experimental group

Treatment:

Drug: CC-95251

CC-95251 + azacitidine

Experimental group

Treatment:

Drug: Azacitidine

Drug: CC-95251

CC-95251 + azacitidine + venetoclax

Experimental group

Treatment:

Drug: Venetoclax