Clinical Trials /

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

NCT04789655

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CC-96191-AML-001
  • SECONDARY ID: U1111-1264-5412
  • NCT ID: NCT04789655

Conditions

  • Leukemia, Myeloid

Interventions

DrugSynonymsArms
CC-96191CC-96191

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
CC-96191ExperimentalCC-96191 will be administered intravenously on a 28-day Cycle
  • CC-96191

Eligibility Criteria

        Inclusion Criteria:

        Participants must satisfy the following criteria to be enrolled in the study:

        1. Participant must understand and voluntarily sign an informed consent form (ICF) prior to
        any study-related assessments/procedures being conducted.

        3. Participant is ≥ 18 years of age at the time of signing the ICF. 4. 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.

        6. Participant has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0,
        1 or 2.

        7. At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion without
        conditioning.

        8. Participants must have adequate hematologic, liver, renal, and coagulation function as
        assessed by laboratory tests 9. Females and males must practice true abstinence or agree to
        contraceptive methods throughout the study, and during the safety follow-up period.

        Exclusion Criteria:

        The presence of any of the following will exclude a Participant from enrollment:

          1. Participant is suspected or proven to have acute promyelocytic leukemia (FAB M3) based
             on morphology, immunophenotype, molecular assay, or karyotype.

          2. 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.

          3. 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).

          4. Prior allogeneic HSCT with either standard or reduced intensity conditioning ≤ 6
             months prior to dosing.

          5. 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.

          6. Participant has persistent, clinically significant non-hematologic toxicities from
             prior therapies which have not recovered to < Grade 2.

          7. 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.

          8. History of concurrent second cancers requiring active, ongoing systemic treatment.

          9. Participant is known seropositive or active infection with human immunodeficiency
             virus (HIV), or active infection with hepatitis B virus or hepatitis C virus.

         10. Impaired cardiac function or clinically significant cardiac diseases, as defined in
             the protocol .

         11. Participant is a pregnant or lactating female.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose limiting toxicities (DLTs)
Time Frame:Up to 42 days after the first dose
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Complete remission rate (CRR)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:As defined by the European Leukemia Net (ELN) AML response criteria.
Measure:Objective response rate (ORR)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:As defined by the European Leukemia Net (ELN) AML response criteria.
Measure:Progression-free survival (PFS)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Is defined as the time from the first dose of CC-96191 to the first occurrence of disease progression or death from any cause.
Measure:Overall survival (OS)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Is measured as the time from the first dose of CC-96191 to death due to any cause.
Measure:Pharmacokinetics - Cmax
Time Frame:Up to 35 days after last dose
Safety Issue:
Description:Maximum serum concentration of drug
Measure:Pharmacokinetics - AUC
Time Frame:Up to 35 days after last dose
Safety Issue:
Description:Area under the serum concentration time-curve
Measure:Pharmacokinetics - tmax
Time Frame:Up to 35 days after last dose
Safety Issue:
Description:Time to peak (maximum) serum concentration
Measure:Pharmacokinetics - t1/2
Time Frame:Up to 35 days after last dose
Safety Issue:
Description:Terminal half-life
Measure:Pharmacokinetics - CL
Time Frame:Up to 35 days after last dose
Safety Issue:
Description:Total body clearance of the drug from the serum
Measure:Pharmacokinetics - Vss
Time Frame:Up to 35 days after last dose
Safety Issue:
Description:Volume of distribution at steady-state
Measure:Presence of anti-drug antibodies (ADA)
Time Frame:Up to 35 days after last dose
Safety Issue:
Description:Detection of anti-drug antibodies in participants
Measure:Frequency of anti-drug antibodies (ADA)
Time Frame:Up to 35 days after last dose
Safety Issue:
Description:Frequency of anti-drug antibodies in participants

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Celgene

Trial Keywords

  • Acute Myeloid Leukemia
  • CC-96191
  • Relapsed or refractory

Last Updated

March 9, 2021