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

Myelodysplastic Syndromes Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05168202
• Other study ID #: CA059-001
• Secondary ID: 2021-002799-38
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 19, 2022
• Est. completion date: June 14, 2026

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 218
• Est. completion date: June 14, 2026
• Est. primary completion date: June 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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 SIRPa 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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• CC-95251
Specified dose on specified days
• Azacitidine
Specified dose on specified days
• Venetoclax
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution - 0006	Clayton	Victoria
Australia	Local Institution - 0005	Heidelberg	Victoria
Australia	Local Institution - 0037	Melbourne	Victoria
Australia	Local Institution - 0027	Wollongong	New South Wales
Canada	Local Institution - 0019	Edmonton	Alberta
Canada	Local Institution - 0038	Montreal	Quebec
Canada	Local Institution - 0010	Toronto	Ontario
Canada	Local Institution - 0011	Vancouver	British Columbia
France	Local Institution - 0040	Marseille
France	Local Institution - 0029	Nantes
France	Local Institution - 0020	Pessac
France	Local Institution - 0023	Toulouse
France	Local Institution - 0041	Villejuif
Italy	Local Institution - 0018	Meldola
Italy	Local Institution - 0026	Milan
Italy	Local Institution - 0017	Rozzano
Norway	Local Institution - 0025	Bergen
Norway	Local Institution - 0013	Oslo
Spain	Local Institution - 0032	Badalona	Barcelona [Barcelona]
Spain	Local Institution - 0039	Barcelona
Spain	Local Institution - 0036	Madrid
Spain	Local Institution - 0035	Salamanca
Spain	Local Institution - 0028	Santander
Sweden	Local Institution - 0021	Gothenburg
Sweden	Local Institution - 0015	Lund
Sweden	Local Institution - 0014	Stockholm
United Kingdom	Local Institution - 0044	Edinburgh	Midlothian
United Kingdom	Local Institution - 0050	Oxford	Oxfordshire
United States	Local Institution - 0001	Houston	Texas
United States	Local Institution - 0030	Los Angeles	California
United States	Local Institution - 0047	Miami	Florida
United States	Local Institution - 0031	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Italy,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a Dose-limiting toxicity (DLT)		Up to 42 days
Primary	Incidence of adverse events (AEs)		Up to 56 days after the last dose of study treatment
Secondary	Complete remission rate (CRR) for acute myeloid leukemia (AML) according to the modified European Leukemia Net (ELN) response criteria		Up to 2 years after end of treatment
Secondary	Overall response rate (ORR) for AML		Up to 2 years after end of treatment
Secondary	CRR for myelodysplastic syndromes (MDS) according to the modified International Working Group (IWG) Response Criteria		Up to 2 years after end of treatment
Secondary	ORR for MDS		Up to 2 years after end of treatment
Secondary	Duration of remission		Up to 2 years after end of treatment
Secondary	Duration of response		Up to 2 years after end of treatment
Secondary	Stable disease rate is the rate of MDS participants whose best response is stable disease		Up to 2 years after end of treatment
Secondary	Relapse-free survival		Up to 2 years after end of treatment
Secondary	Event-free survival		Up to 2 years after end of treatment
Secondary	Progression-free survival		Up to 2 years after end of treatment
Secondary	Time to remission/response		Up to 2 years after end of treatment
Secondary	Transfusion independence		Up to 2 years after end of treatment
Secondary	Time to AML transformation for MDS participants		Up to 2 years after end of treatment
Secondary	Overall survival (OS) rates at 6 months		Up to 2 years after end of treatment
Secondary	OS rates at 12 months		Up to 2 years after end of treatment
Secondary	Maximum plasma concentration of drug (Cmax)		Up to 8 weeks post-dose of CC-95251
Secondary	Minimum serum concentration (Cmin)		Up to 8 weeks post-dose of CC-95251
Secondary	Trough observed serum concentration (Ctrough)		Up to 8 weeks post-dose of CC-95251
Secondary	Presence of anti-CC-95251 antibodies (ADAs) using a validated electrochemiluminescence (ECL) assay		Up to 8 weeks post-dose of CC-95251
Secondary	Frequency of ADAs using a validated ECL assay		Up to 8 weeks post-dose of CC-95251

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting