A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT05168202 Recruiting December 23, 2021 March 14, 2022

study description
Brief 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.

Condition or Disease: Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Intervention/treatment: Drug: CC-95251
Drug: Azacitidine
Phase: Phase 1
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 30 participants
Allocation : Non-Randomized
Intervention Model : Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Actual Study Start Date: January 2022
Estimated Primary Completion Date: June 2026
Estimated Study Completion Date: June 2026

Arms and interventions
Arm Intervention/treatment
Experimental: CC-95251 + azacitidine
Drug: CC-95251
Specified dose on specified days

Drug: Azacitidine
Specified dose on specified days
Experimental: CC-95251 monotherapy
Drug: CC-95251
Specified dose on specified days
outcome measures
Primary Outcome Measures: 1. Number of participants with a Dose-limiting toxicity (DLT) [ Time Frame: Up to 42 days ]
2. Incidence of adverse events (AEs) [ Time Frame: Up to 56 days after the last dose of study treatment ]
Secondary Outcome Measures: 1. Complete remission rate (CRR) for acute myeloid leukemia (AML) according to the modified European Leukemia Net (ELN) response criteria [ Time Frame: Up to 2 years after end of treatment ]
2. Overall response rate (ORR) for AML [ Time Frame: Up to 2 years after end of treatment ]
3. CRR for myelodysplastic syndromes (MDS) according to the modified International Working Group (IWG) Response Criteria [ Time Frame: Up to 2 years after end of treatment ]
4. ORR for MDS [ Time Frame: Up to 2 years after end of treatment ]
5. Duration of remission [ Time Frame: Up to 2 years after end of treatment ]
6. Duration of response [ Time Frame: Up to 2 years after end of treatment ]
7. Stable disease rate is the rate of MDS participants whose best response is stable disease [ Time Frame: Up to 2 years after end of treatment ]
8. Relapse-free survival [ Time Frame: Up to 2 years after end of treatment ]
9. Event-free survival [ Time Frame: Up to 2 years after end of treatment ]
10. Progression-free survival [ Time Frame: Up to 2 years after end of treatment ]
11. Time to remission/response [ Time Frame: Up to 2 years after end of treatment ]
12. Transfusion independence [ Time Frame: Up to 2 years after end of treatment ]
13. Time to AML transformation for MDS participants [ Time Frame: Up to 2 years after end of treatment ]
14. Overall survival (OS) rates at 6 months [ Time Frame: Up to 2 years after end of treatment ]
15. OS rates at 12 months [ Time Frame: Up to 2 years after end of treatment ]
16. Maximum plasma concentration of drug (Cmax) [ Time Frame: Up to 8 weeks post-dose of CC-95251 ]
17. Minimum serum concentration (Cmin) [ Time Frame: Up to 8 weeks post-dose of CC-95251 ]
18. Trough observed serum concentration (Ctrough) [ Time Frame: Up to 8 weeks post-dose of CC-95251 ]
19. Presence of anti-CC-95251 antibodies (ADAs) using a validated electrochemiluminescence (ECL) assay [ Time Frame: Up to 8 weeks post-dose of CC-95251 ]
20. Frequency of ADAs using a validated ECL assay [ Time Frame: Up to 8 weeks post-dose of CC-95251 ]

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

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 (ie, previously untreated) MDS as defined by the 2016 WHO Classification with intermediate, high or very high risk by IPSS-R

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


Contacts and Locations
Contacts

Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com/ 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

Locations
United States, California Local Institution Marina Del Rey
United States, California Local Institution Stanford
United States, Florida Local Institution Miami
United States, Illinois Local Institution Chicago
United States, New York Local Institution Buffalo
United States, Texas Local Institution Houston
United States, Washington Local Institution Seattle
Australia, New South Wales Local Institution Wollongong
Australia, Victoria Local Institution Clayton
Australia, Victoria Local Institution Fitzroy
Australia, Victoria Local Institution Heidelberg
Canada, Alberta Local Institution Edmonton
Canada, British Columbia Local Institution Vancouver
Canada, Ontario Local Institution Toronto
Canada, Quebec Local Institution Montreal
Denmark Local Institution Odense
France Local Institution Marseille
France Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-hematology Nantes
France Local Institution Pessac
France Institut Claudius Regaud Toulouse
France Local Institution Villejuif
Italy Local Institution Meldola
Italy Local Institution Milan
Italy Local Institution Rozzano
Norway Local Institution Bergen
Norway Local Institution Oslo
Spain Local Institution Badalona
Spain Local Institution Barcelona
Spain Local Institution Madrid
Spain Local Institution Salamanca
Spain Local Institution Santander
Sweden Local Institution Goteborg
Sweden Local Institution Huddinge
Sweden Local Institution Lund
United Kingdom Local Institution Edinburgh
United Kingdom Local Institution Oxford
Sponsors and Collaborators
Bristol-Myers Squibb
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT05168202     
Other Study ID Numbers : CA059-001, 2021-002799-38
First Posted : December 23, 2021
Last Update Posted : March 14, 2022
Last Verified : March 2022
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb: Myelodysplastic Syndromes
Acute Myeloid Leukemia
AML
MDS
Hematologic Cancers
Leukemia
Anti-SIRPa antibody
CC-95251
Additional relevant MeSH terms :
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions