Clinical trial NCT05168202: A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Keywords: Myelodysplastic Syndromes
Acute Myeloid Leukemia
AML
MDS
Hematologic Cancers
Leukemia
Anti-SIRPa antibody
CC-95251
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-12-23
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 (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

Primary outcomes:
measure: Number of participants with a Dose-limiting toxicity (DLT)
timeFrame: Up to 42 days
measure: Incidence of adverse events (AEs)
timeFrame: Up to 56 days after the last dose of study treatment
Secondary outcomes:
measure: Complete remission rate (CRR) for acute myeloid leukemia (AML) according to the modified European Leukemia Net (ELN) response criteria
timeFrame: Up to 2 years after end of treatment
measure: Overall response rate (ORR) for AML
timeFrame: Up to 2 years after end of treatment
measure: CRR for myelodysplastic syndromes (MDS) according to the modified International Working Group (IWG) Response Criteria
timeFrame: Up to 2 years after end of treatment
measure: ORR for MDS
timeFrame: Up to 2 years after end of treatment
measure: Duration of remission
timeFrame: Up to 2 years after end of treatment
measure: Duration of response
timeFrame: Up to 2 years after end of treatment
measure: Stable disease rate is the rate of MDS participants whose best response is stable disease
timeFrame: Up to 2 years after end of treatment
measure: Relapse-free survival
timeFrame: Up to 2 years after end of treatment
measure: Event-free survival
timeFrame: Up to 2 years after end of treatment
measure: Progression-free survival
timeFrame: Up to 2 years after end of treatment
measure: Time to remission/response
timeFrame: Up to 2 years after end of treatment
measure: Transfusion independence
timeFrame: Up to 2 years after end of treatment
measure: Time to AML transformation for MDS participants
timeFrame: Up to 2 years after end of treatment
measure: Overall survival (OS) rates at 6 months
timeFrame: Up to 2 years after end of treatment
measure: OS rates at 12 months
timeFrame: Up to 2 years after end of treatment
measure: Maximum plasma concentration of drug (Cmax)
timeFrame: Up to 8 weeks post-dose of CC-95251
measure: Minimum serum concentration (Cmin)
timeFrame: Up to 8 weeks post-dose of CC-95251
measure: Trough observed serum concentration (Ctrough)
timeFrame: Up to 8 weeks post-dose of CC-95251
measure: Presence of anti-CC-95251 antibodies (ADAs) using a validated electrochemiluminescence (ECL) assay
timeFrame: Up to 8 weeks post-dose of CC-95251
measure: Frequency of ADAs using a validated ECL assay
timeFrame: Up to 8 weeks post-dose of CC-95251
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Local Institution - 0030
state: California
city: Palo Alto
country: United States
facility: Local Institution - 0031
state: California
city: Miami
country: United States
facility: Local Institution - 0047
state: Florida
city: Houston
country: United States
facility: Local Institution - 0001
state: Texas
city: Wollongong
country: Australia
facility: Local Institution - 0027
state: New South Wales
city: Clayton
country: Australia
facility: Local Institution - 0006
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution - 0005
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0037
state: Victoria
city: Edmonton
country: Canada
facility: Local Institution - 0019
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution - 0011
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution - 0010
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0038
state: Quebec
city: Marseille
country: France
facility: Local Institution - 0040
city: Nantes
country: France
facility: Local Institution - 0029
city: Pessac
country: France
facility: Local Institution - 0020
city: Toulouse
country: France
facility: Local Institution - 0023
city: Villejuif
country: France
facility: Local Institution - 0041
city: Meldola
country: Italy
facility: Local Institution - 0018
state: Emilia-Romagna
city: Milan
country: Italy
facility: Local Institution - 0026
city: Rozzano
country: Italy
facility: Local Institution - 0017
city: Bergen
country: Norway
facility: Local Institution - 0025
city: Oslo
country: Norway
facility: Local Institution - 0013
city: Badalona
country: Spain
facility: Local Institution - 0032
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Local Institution - 0039
city: Madrid
country: Spain
facility: Local Institution - 0036
city: Salamanca
country: Spain
facility: Local Institution - 0035
city: Santander
country: Spain
facility: Local Institution - 0028
city: Gothenburg
country: Sweden
facility: Local Institution - 0021
city: Lund
country: Sweden
facility: Local Institution - 0015
city: Stockholm
country: Sweden
facility: Local Institution - 0014
city: Edinburgh
country: United Kingdom
facility: Local Institution - 0044
state: Midlothian
city: Oxford
country: United Kingdom
facility: Local Institution - 0050
state: Oxfordshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: