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Experimental leukemia drug trial halted early

NCT ID NCT05168202

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new drug called CC-95251, alone or with other cancer drugs, in people with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) that had come back or not responded to treatment. The main goals were to check safety and find the right dose. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

56 people

The number who actually took part.

Started

Jan 2022

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia leukemia myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leukemia, myeloid, acute Myelodysplastic syndromes

Contacts and locations

Locations

  • Local Institution - 0001

    Houston, Texas, 77030, United States

  • Local Institution - 0005

    Heidelberg, Victoria, 3084, Australia

  • Local Institution - 0006

    Clayton, Victoria, 3168, Australia

  • Local Institution - 0010

    Toronto, Ontario, M5G 2M9, Canada

  • Local Institution - 0011

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Local Institution - 0013

    Oslo, N-0027, Norway

  • Local Institution - 0014

    Stockholm, 141 86, Sweden

  • Local Institution - 0015

    Lund, 22185, Sweden

  • Local Institution - 0017

    Rozzano, 20089, Italy

  • Local Institution - 0018

    Meldola, Emilia-Romagna, 47014, Italy

  • Local Institution - 0019

    Edmonton, Alberta, T6G 2B7, Canada

  • Local Institution - 0020

    Pessac, 33600, France

  • Local Institution - 0021

    Gothenburg, 413 45, Sweden

  • Local Institution - 0023

    Toulouse, 31059, France

  • Local Institution - 0025

    Bergen, 5021, Norway

  • Local Institution - 0026

    Milan, 20162, Italy

  • Local Institution - 0027

    Wollongong, New South Wales, 2500, Australia

  • Local Institution - 0028

    Santander, 39008, Spain

  • Local Institution - 0029

    Nantes, 44000, France

  • Local Institution - 0030

    Los Angeles, California, 90095, United States

  • Local Institution - 0031

    Palo Alto, California, 94304, United States

  • Local Institution - 0032

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Local Institution - 0035

    Salamanca, 37007, Spain

  • Local Institution - 0036

    Madrid, 28007, Spain

  • Local Institution - 0037

    Melbourne, Victoria, 3065, Australia

  • Local Institution - 0038

    Montreal, Quebec, H3T 1E2, Canada

  • Local Institution - 0039

    Barcelona, 08041, Spain

  • Local Institution - 0040

    Marseille, 13009, France

  • Local Institution - 0041

    Villejuif, 94805, France

  • Local Institution - 0044

    Edinburgh, Midlothian, EH4 2XU, United Kingdom

  • Local Institution - 0047

    Miami, Florida, 33136, United States

  • Local Institution - 0050

    Oxford, Oxfordshire, OX3 7LE, United Kingdom

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