AzTrials
AzTrials

Leukemia, MyeloidPhase 1NCT04789655

Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1 study testing CC-96191 in people with Leukemia, Myeloid, run by Celgene at 14 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Myeloid
What is being tested?
CC-96191
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
14 sitesin 3 countries
Study dates
16 Jun 2021to 14 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must satisfy the following criteria to be enrolled in the study:.
  • Participant must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
  • Participant is ≥ 18 years of age at the time of signing the ICF.
  • Relapsed or refractory CD33 positive AML at last visit as defined by the World Health Organization (WHO) Classification who have failed or who are ineligible for or have refused all available therapies for AML which may provide clinical benefit.
  • Participant has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion without conditioning.
  • Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and during the safety follow-up period.

Who cannot join

  • The presence of any of the following will exclude a Participant from enrollment:.
  • Participant is suspected or proven to have acute promyelocytic leukemia (FAB M3) based on morphology, immunophenotype, molecular assay, or karyotype.
  • Participant has received systemic anticancer therapy (including investigational therapy) or radiotherapy < 28 days or 5 half-lives, whichever is shorter, prior to the start of study treatment. Hydroxyurea is allowed to control peripheral leukemia blasts.
  • Participants with prior autologous hematopoietic stem cell transplant who, in the investigator's judgment, have not fully recovered from the effects of the last transplant (eg, transplant-related side effects).
  • Prior allogeneic HSCT with either standard or reduced intensity conditioning ≤ 6 months prior to dosing.
  • Participants on systemic immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). The use of topical steroids for ongoing skin or ocular GVHD is permitted.
Show all 15Show fewer
  • Participant has persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to < Grade 2.
  • Participant has or is suspected of having central nervous system (CNS) leukemia. Evaluation of cerebrospinal fluid is only required if CNS involvement by leukemia is suspected during screening.
  • History of concurrent second cancers requiring active, ongoing systemic treatment.
  • Participant is known seropositive or active infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus or hepatitis C virus.
  • Impaired cardiac function or clinically significant cardiac diseases, as defined in the protocol.
  • Participant is a pregnant or lactating female.
  • Participant with isolated extramedullary disease without bone marrow involvement.
  • Inadequate pulmonary function as defined as oxygen saturation (SpO2) < 92% on room air.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

14 sites in 3 countries.

14 sites in 3 countries

United States8 sites

  • Local Institution - 108

    Atlanta, Georgia, 30322

  • Local Institution - 109

    Birmingham, Alabama, 35233

  • Local Institution - 101

    Hackensack, New Jersey, 07601

  • Local Institution - 107

    Houston, Texas, 77030-4009

  • Local Institution - 105

    Jacksonville, Florida, 32224

  • Local Institution - 102

    New York, New York, 10029

  • Local Institution - 110

    Rochester, Minnesota, 55905

  • Local Institution - 111

    Seattle, Washington, 98104

Other trials in United States

France4 sites

  • Local Institution - 303

    Marseille, 13273

  • Local Institution - 304

    Paris, 75010

  • Local Institution - 301

    Pessac, 33604

  • Local Institution - 302

    Villejuif, 94805

Other trials in France

Canada2 sites

  • Local Institution - 202

    Calgary, Alberta, T2N 5G2

  • Local Institution - 201

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-96191 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML).

The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy.

The expansion (Part B), will further evaluate the safety and efficacy of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D.

Being tested
CC-96191
Keywords
Acute Myeloid Leukemia, CC-96191, Relapsed or refractory
Medical subject headings
Leukemia, Myeloid, Leukemia, Myeloid, Acute, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-96191Drug

    CC-96191

Study groups in NCT04789655
Study groupRoleWhat they receive
CC-96191ExperimentalCC-96191 will be administered intravenously on a 28-day Cycle
Receives: Drug: CC-96191

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicities (DLTs)

    Are defined as toxicities that meet the protocol-specified criteria occurring within the DLT assessment window (Cycle 1, Days 1 to at least 28 and up to 42 days) that cannot be attributed to a clearly identifiable cause such as underlying illness, disease progression, other concurrent illness, or concomitant medication.

    Measured: Up to 42 days after the first dose

  2. Maximum tolerated dose (MTD)

    Is defined as the highest dose at which less than 33% of the population treated with CC-96191 experience a dose limiting toxicity (DLT) in the first cycle.

    Measured: Up to 35 days after the last dose

  3. Adverse Events (AEs)

    Type, frequency, seriousness, severity and relationship of AEs to CC-96191

    Measured: Up to 35 days after the last dose

Secondary outcomes (14)

  1. Complete remission rate (CRR)

    As defined by the European Leukemia Net (ELN) AML response criteria.

    Measured: Up to approximately 2 years

  2. Objective response rate (ORR)

    As defined by the European Leukemia Net (ELN) AML response criteria.

    Measured: Up to approximately 2 years

  3. Progression-free survival (PFS)

    Is defined as the time from the first dose of CC-96191 to the first occurrence of disease progression or death from any cause.

    Measured: Up to approximately 2 years

  4. Overall survival (OS)

    Is measured as the time from the first dose of CC-96191 to death due to any cause.

    Measured: Up to approximately 2 years

  5. Duration of remission

    For subjects with best response of complete remission (CR) of any type, morphologic leukemia free state (MLFS) or partial remission (PR), duration of response (DOR) is measured from the time when criteria for CR/MLFS/PR are first met (whichever is first recorded) until the first date at which relapse, or progressive disease is objectively documented

    Measured: Up to approximately 2 years

  6. Time to remission

    Time from the date of first dose to the earliest date of any response (CR of any type, MLFS or PR)

    Measured: Up to approximately 2 years

  7. Pharmacokinetics - Cmax

    Maximum serum concentration of drug

    Measured: Up to 35 days after last dose

  8. Pharmacokinetics - AUC

    Area under the serum concentration time-curve

    Measured: Up to 35 days after last dose

  9. Pharmacokinetics - tmax

    Time to peak (maximum) serum concentration

    Measured: Up to 35 days after last dose

  10. Pharmacokinetics - t1/2

    Terminal half-life

    Measured: Up to 35 days after last dose

  11. Pharmacokinetics - CL

    Total body clearance of the drug from the serum

    Measured: Up to 35 days after last dose

  12. Pharmacokinetics - Vss

    Volume of distribution at steady-state

    Measured: Up to 35 days after last dose

  13. Presence of anti-drug antibodies (ADA)

    Detection of anti-drug antibodies in participants

    Measured: Up to 35 days after last dose

  14. Frequency of anti-drug antibodies (ADA)

    Frequency of anti-drug antibodies in participants

    Measured: Up to 35 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2021
  2. Study start16 Jun 2021
  3. Primary completion14 Apr 2025
  4. Study completion14 Apr 2025

Why it stopped: Business objectives have changed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04789655
Sponsor's protocol ID
CC-96191-AML-001
Other IDs
U1111-1264-5412, 2022-500573-13-00
Status last verified
May 2025
First submitted
26 Feb 2021
Last updated
31 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Publications

  • Lunn-Halbert MC, Laszlo GS, Erraiss S, Orr MT, Jessup HK, Thomas HJ, Chan H, Jahromi MA, Lloyd J, Cheung AF, Chang GP, Dichwalkar T, Fallon D, Grinberg A, Rodriguez-Arboli E, Lim SYT, Kehret AR, Huo J, Cole FM, Scharffenberger SC, Walter RB. Preclinical Characterization of the Anti-Leukemia Activity of the CD33/CD16a/NKG2D Immune-Modulating TriNKET(R) CC-96191. Cancers (Basel). 2024 Feb 22;16(5):877. doi: 10.3390/cancers16050877.

    PubMed 38473239

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-96191 in people with Leukemia, Myeloid, run by Celgene at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, France, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicities (DLTs) (time frame: Up to 42 days after the first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04789655, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in