A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)

NCT02641002 | Terminated Phase 1

• 1 other identifier: CC-90002-AML-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 6

Brief Summary

Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with relapsed and/or primary refractory AML and high-risk MDS. The study will explore escalating doses of CC-90002 using a 3 + 3 dose escalation design in Part A, followed by dose expansion in Part B. The primary objective is to determine the safety and tolerability of CC-90002 and also to define the non-tolerated dose (NTD), the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-90002.

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Keywords

CC-90002; Monoclonal; Antibody; CD47; Hematologic Cancers; Acute Myeloid Leukemia; AML; Myelodysplastic syndrome; MDS; Blood disorder

Outcome Measures

Primary Outcomes (3)

• Dose-limiting Toxicity (DLT)

  Number of participants with a DLT

  Up to 26 months

• Non-tolerated Dose (NTD)

  The NTD is defined as the dose at which 2 or more of up to 6 evaluable subjects in a cohort experience a DLT in Cycle 1

  Up to 26 months

• Maximum tolerated dose (MTD)

  The MTD is defined as the last dose level(s) below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during Cycle 1.

  Up to 26 months

Secondary Outcomes (8)

• Preliminary Efficacy of CC-90002

  Up to 35 months

• Pharmacokinetics-Cmax

  Up to 35 months

• Pharmacokinetics-AUC

  Up to 35 months

• Pharmacokinetics-Tmax

  Up to 35 months

• Pharmacokinetics-T 1/2

  Up to 35 months

Study Arms (1)

Dose escalation of CC-90002

EXPERIMENTAL

CC-90002 by intravenous (IV) infusion on a 28 day cycle

Drug: CC-90002

Interventions

CC-90002 DRUG

Monoclonal Ab to CD47

Dose escalation of CC-90002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥ 18 years of age, at the time of signing the informed consent form (ICF).
• Relapsed and/or primary refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) with subtype refractory anemia with excess blasts (RAEB)-2 defined as high or very high-risk that is recurrent or refractory, or the patient is intolerant to established therapy.
• Subject consents to hospitalization for first (Cycle 1 Day 1) dose of CC-90002 and for 72 hours after.
• Subject consents to serial bone marrow aspiration and biopsies as specified.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
• Eligible study subjects must exhibit acceptable liver, renal, and coagulation function as assessed by laboratory tests.
• Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and for up to 8 weeks following the last dose of CC 90002.

You may not qualify if:

• Active central nervous system (CNS) leukemia or known CNS leukemia.
• Immediately life-threatening, severe complications of leukemia.
• Impaired cardiac function or clinically significant cardiac diseases.
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• Prior autologous hematopoietic stem cell transplant ≤ 3 months.
• Prior allogeneic hematopoietic stem cell transplant (HSCT) with either standard or reduced intensity conditioning ≤ 6 months.
• Systemic immunosuppressive therapy post HSCT or with clinically significant graft-versus-host disease (GVHD).
• Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks whichever is shorter.
• Major surgery ≤ 2 weeks and recovered from any clinically significant effects of recent surgery.
• Pregnant or nursing females.
• Known HIV infection.
• Known chronic hepatitis B or C (HBV/HCV) infection.
• Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
• History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
• History of concurrent second cancers requiring active, ongoing systemic treatment.

Sponsors & Collaborators

• Celgene: lead

Study Sites (6)

Mayo Clinic Phoenix

Phoenix, Arizona, 85054, United States

Location

UCLA Division of Hematology Oncology

Los Angeles, California, 90095-1752, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

• Narla RK, Modi H, Bauer D, Abbasian M, Leisten J, Piccotti JR, Kopytek S, Eckelman BP, Deveraux Q, Timmer J, Zhu D, Wong L, Escoubet L, Raymon HK, Hariharan K. Modulation of CD47-SIRPalpha innate immune checkpoint axis with Fc-function detuned anti-CD47 therapeutic antibody. Cancer Immunol Immunother. 2022 Feb;71(2):473-489. doi: 10.1007/s00262-021-03010-6. Epub 2021 Jul 10.

  PMID: 34247273 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Hematologic Diseases

Interventions

CC-90002

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Study Officials

• Michael Burgess, MD, PhD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: December 29, 2015
• Study Start: March 1, 2016
• Primary Completion: July 18, 2018
• Study Completion: July 18, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

US (6)