Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

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

Keywords

Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Acute Myeloid Leukemia, AML, MDS, Hematologic Cancers, Leukemia, Anti-SIRPa antibody, CC-95251, Myeloid Leukemia, Preleukemia, Syndrome, Azacitidine, Venetoclax, CC-95251 monotherapy, CC-95251 + azacitidine, CC-95251 + azacitidine + venetoclax

Eligibility

You can join if…

Open to people ages 18 years and up

• 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)

You CAN'T join if...

  • 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

Locations

  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) accepting new patients
    Los Angeles California 90095 United States
  • Stanford Cancer Center-Hematology accepting new patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT05168202
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 218 study participants
Last Updated