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Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)

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ClinicalTrials.gov Identifier: NCT02715011
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to characterize the safety and tolerability of JNJ-63709178 and identify the recommended Phase 2 dose(s) (RP2D) and schedule for JNJ-63709178 in Part 1 and to characterize the safety and tolerability of JNJ-63709178 at the RP2D(s) in Part 2.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: JNJ-63709178 Phase 1

Detailed Description:
This is first-in-human (FIH) Phase 1, open-label (identity of assigned study drug will be known), multicenter, dose escalation study with dose expansion to identify the RP2D and to evaluate the safety, tolerability, and preliminary antitumor activity of JNJ-63709178 in adult subjects with relapsed or refractory acute myeloid leukemia (AML) who are ineligible for or have exhausted standard therapeutic options. The study is divided into 3 periods: a Screening Phase (within 28 days before the first dose of study drug), a Treatment Phase (first dose of study drug until the last dose of study drug) and a Post-treatment Follow-up Phase (up to the end of study participation or end of study). Subjects' safety will be monitored throughout the study.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Subjects With Relapsed or Refractory AML
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : October 29, 2020
Estimated Study Completion Date : October 29, 2020


Arms and Interventions

Arm Intervention/treatment
Experimental: Part 1: Dose Escalation
The first cohort of subjects will receive intravenous infusions of JNJ-63709178 at a dose of 2 microgram/kilogram. Each subsequent cohort will receive intravenous infusions of JNJ-63709178 at an increased dose level. Dose escalation will continue until the maximum tolerated dose is reached or all planned doses are administered. Subjects will receive intravenous infusion of JNJ-63709178 once every 2 weeks. The duration of each treatment cycle is 28 days.
Drug: JNJ-63709178
Intravenous infusion of JNJ-63709178 once every 2 weeks. The duration of each treatment cycle is 28 days.
Experimental: Part 2: Dose Expansion
Subjects will receive intravenous infusion of JNJ-63709178 at the recommended Phase 2 dose(s) (RP2D) and schedule once every 2 weeks. The duration of each treatment cycle is 28 days.
Drug: JNJ-63709178
Intravenous infusion of JNJ-63709178 once every 2 weeks. The duration of each treatment cycle is 28 days.


Outcome Measures

Primary Outcome Measures :
  1. Part 1: Number of subjects with dose-limiting toxicity (DLT) [ Time Frame: Up to Day 28 ]
  2. Part 1: Type of dose-limiting toxicity (DLT) [ Time Frame: Up to Day 28 ]
  3. Part 2: Occurence of adverse events and serious adverse events [ Time Frame: Up to 1.5 years ]
  4. Part 2: Severity of adverse events and serious adverse events [ Time Frame: Up to 1.5 years ]

Secondary Outcome Measures :
  1. Part 2: Serum concentration of JNJ-63709178 [ Time Frame: Up to 1.5 years ]
  2. Part 2: JNJ-63709178 Receptor occupancy [ Time Frame: Up to 1.5 years ]
  3. Part 2: Number of subjects with depletion of CD123 expressing cells [ Time Frame: Up to 1.5 years ]
  4. Part 2: Systemic cytokine concentration [ Time Frame: Up to 1.5 years ]
  5. Part 2: Concentration of markers of T cell activation [ Time Frame: Up to 1.5 years ]
  6. Part 2: Anti- JNJ-63709178 antibodies concentration [ Time Frame: Up to 1.5 years ]
  7. Part 2: Overall response rate (ORR) [ Time Frame: Up to 1.5 years ]
    ORR rate is defined as the rate of complete response (CR) plus CR with incomplete recovery (CRi).

  8. Part 2: Event-free survival (EFS) [ Time Frame: Up to 1.5 years ]
    EFS is defined as time from start of treatment to the date of an event, that is, first documented treatment failure, relapse from CR/CRi, or death due to any cause.

  9. Part 2: Relapse-free survival (RFS) [ Time Frame: Up to 1.5 years ]
    RFS is defined as time from CR or CRi confirmed objective of response to relapse from CR or CRi or to death from any cause.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of acute myeloid leukemia (AML) according to the World Health Organization 2008 criteria with relapsed or refractory disease and ineligible for or have exhausted standard therapeutic options.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Hematology laboratory parameters within the Protocol specified range
  • Chemistry laboratory parameters within the Protocol specified range
  • A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin [b-hCG]) or urine test prior to the first dose of study drug

Exclusion Criteria:

  • Acute promyelocytic leukemia
  • Active central nervous system involvement
  • Prior solid organ transplantation
  • Prior hematopoietic stem cell transplant within 6 months of enrollment. If the subject has had an allogenic transplant there must be no apparent signs of graft versus host disease and subjects must be off all immunosuppressive therapies
  • Prior treatment with a CD123xCD3 bispecific agent, T cells expressing CD123 specific chimeric antigen receptor, or toxin-conjugated to CD123 antibodies; prior treatment with naked anti-CD123 monoclonal antibody is permitted
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715011


Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
United States, Maryland
University of Maryland Withdrawn
Baltimore, Maryland, United States, 21201
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
United States, New Jersey
Hackensack University Medical Center Withdrawn
Hackensack, New Jersey, United States, 07601
United States, New York
Weill Cornell Medical College / New York Presbyterian Hospital Recruiting
New York, New York, United States, 10021
Memorial Sloan Kettering Cancer Center Withdrawn
New York, New York, United States, 10065
University of Rochester Withdrawn
Rochester, New York, United States, 14627
United States, North Carolina
Levine Cancer Institute, Carolinas HealthCare System Recruiting
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Sarah Cannon Research Institute Completed
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas, MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Spain
Hosp. Univ. Vall D Hebron Not yet recruiting
Barcelona, Spain, 08035
Hosp. Univ. Fund. Jimenez Diaz Not yet recruiting
Madrid, Spain, 28040
Hosp. Virgen Del Rocio Not yet recruiting
Sevilla, Spain, 41013
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02715011     History of Changes
Other Study ID Numbers: CR108147
63709178AML1001 ( Other Identifier: Janssen Research & Development, LLC )
2016-000208-27 ( EudraCT Number )
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Leukemia, Myeloid, Acute
JNJ-63709178

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms