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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
First received
Last updated
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
Health authority
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

Study Design


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
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