CC-95251 for Leukemia

Recruiting in Palo Alto (17 mi)

+79 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called CC-95251 to see if it can help treat patients with difficult-to-treat blood cancers. The study will check if the drug is safe and effective when used alone or with other cancer treatments.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), as well as treatment-naive MDS at higher risk. Participants should be able to perform daily activities with minimal assistance. They can't join if they have life-threatening complications, prior treatments with similar drugs, uncontrolled infections, recent cancer treatments, are on immunosuppressants, or are pregnant/nursing.

Inclusion Criteria

I have a type of leukemia that can't be treated with intense chemo or stem cell transplant.

My condition is a type of blood disorder classified as intermediate, high, or very high risk.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

Pregnant or nursing participants

I haven't had cancer treatments or experimental drugs within the last 4 weeks or 5 half-lives, whichever is shorter.

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

Treatment Details

Interventions

• Azacitidine (Anti-metabolites)
• CC-95251 (Other)

Trial Overview The study tests the safety and effectiveness of CC-95251 alone and combined with other cancer drugs in treating AML and MDS. It's looking at how well patients respond to the treatment and what side effects occur when using CC-95251 with Azacitidine and Venetoclax.

Participant Groups

Group I: CC-95251 monotherapy Experimental Treatment 1 Intervention

Group II: CC-95251 + azacitidine + venetoclax Experimental Treatment 1 Intervention

Group III: CC-95251 + azacitidine Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania