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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05168202

Collaborator

(none)

Enrollment

Locations

Arms

52.8

Anticipated Duration (Months)

0.8

Patients Per Site

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
Leukemia, Myeloid, Acute Myelodysplastic Syndromes	Drug: CC-95251 Drug: Azacitidine	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 19, 2022

Anticipated Primary Completion Date :

Jun 14, 2026

Anticipated Study Completion Date :

Jun 14, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CC-95251 monotherapy	Drug: CC-95251 Specified dose on specified days
Experimental: CC-95251 + azacitidine	Drug: CC-95251 Specified dose on specified days Drug: Azacitidine Specified dose on specified days

Arm

Intervention/Treatment

Experimental: CC-95251 monotherapy

Drug: CC-95251

Specified dose on specified days

Experimental: CC-95251 + azacitidine

Drug: CC-95251

Specified dose on specified days

Drug: Azacitidine

Specified dose on specified days

Outcome Measures

Primary Outcome Measures

Number of participants with a Dose-limiting toxicity (DLT) [Up to 42 days]
Incidence of adverse events (AEs) [Up to 56 days after the last dose of study treatment]

Secondary Outcome Measures

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]
Overall response rate (ORR) for AML [Up to 2 years after end of treatment]
CRR for myelodysplastic syndromes (MDS) according to the modified International Working Group (IWG) Response Criteria [Up to 2 years after end of treatment]
ORR for MDS [Up to 2 years after end of treatment]
Duration of remission [Up to 2 years after end of treatment]
Duration of response [Up to 2 years after end of treatment]
Stable disease rate is the rate of MDS participants whose best response is stable disease [Up to 2 years after end of treatment]
Relapse-free survival [Up to 2 years after end of treatment]
Event-free survival [Up to 2 years after end of treatment]
Progression-free survival [Up to 2 years after end of treatment]
Time to remission/response [Up to 2 years after end of treatment]
Transfusion independence [Up to 2 years after end of treatment]
Time to AML transformation for MDS participants [Up to 2 years after end of treatment]
Overall survival (OS) rates at 6 months [Up to 2 years after end of treatment]
OS rates at 12 months [Up to 2 years after end of treatment]
Maximum plasma concentration of drug (Cmax) [Up to 8 weeks post-dose of CC-95251]
Minimum serum concentration (Cmin) [Up to 8 weeks post-dose of CC-95251]
Trough observed serum concentration (Ctrough) [Up to 8 weeks post-dose of CC-95251]
Presence of anti-CC-95251 antibodies (ADAs) using a validated electrochemiluminescence (ECL) assay [Up to 8 weeks post-dose of CC-95251]
Frequency of ADAs using a validated ECL assay [Up to 8 weeks post-dose of CC-95251]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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 (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

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Marina Del Rey	California	United States	90292
2	Local Institution	Stanford	California	United States	94305
3	Local Institution	Miami	Florida	United States	33136
4	Local Institution	Chicago	Illinois	United States	60611
5	Local Institution	Buffalo	New York	United States	14263
6	UT Southwestern-Harold C. Simmons Cancer Center	Dallas	Texas	United States	75235
7	Local Institution	Houston	Texas	United States	77030
8	Local Institution	Seattle	Washington	United States	98104
9	Local Institution	Wollongong	New South Wales	Australia	2500
10	Local Institution	Clayton	Victoria	Australia	3168
11	Local Institution	Fitzroy	Victoria	Australia	3065
12	Local Institution	Heidelberg	Victoria	Australia	3084
13	Local Institution - 0019	Edmonton	Alberta	Canada	T6G 2B7
14	Local Institution	Vancouver	British Columbia	Canada	V5Z 1L9
15	Local Institution	Toronto	Ontario	Canada	M5G 2M9
16	Local Institution	Montreal	Quebec	Canada	H3t1e2
17	Local Institution	Odense		Denmark	5000
18	Local Institution	Marseille		France	13273
19	Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-hematology	Nantes		France	44093
20	Local Institution	Pessac		France	33604
21	Institut Claudius Regaud	Toulouse		France	31100
22	Local Institution	Villejuif		France	94805
23	Local Institution	Meldola		Italy	47014
24	Local Institution	Milan		Italy	20162
25	Local Institution	Rozzano		Italy	20089
26	Local Institution	Bergen		Norway	5012
27	Local Institution	Oslo		Norway	0424
28	Local Institution	Badalona		Spain	08916
29	Local Institution	Barcelona		Spain	08049
30	Local Institution	Madrid		Spain	28007
31	Local Institution - 0035	Salamanca		Spain	37007
32	Local Institution	Santander		Spain	39008
33	Local Institution	Goteborg		Sweden	41345
34	Local Institution	Huddinge		Sweden	141 86
35	Local Institution	Lund		Sweden	222 42
36	Local Institution	Edinburgh		United Kingdom	EH4 2XU
37	Local Institution	Oxford		United Kingdom	OX3 7LE