A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Trial ID or NCT#
NCT05168202
Status
NOT RECRUITING
Purpose
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.
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Ji Hyun Choi
+1 650-723-1367
View on ClinicalTrials.gov
