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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715011
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE March 16, 2016
First Posted Date  ICMJE March 22, 2016
Last Update Posted Date September 11, 2020
Actual Study Start Date  ICMJE June 2016
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
  • Part 1: Number of participants with dose-limiting toxicity (DLT) [ Time Frame: Up to Day 28 ]
  • Part 1: Type of dose-limiting toxicity (DLT) [ Time Frame: Up to Day 28 ]
  • Part 2: Number of participants with adverse events and serious adverse events [ Time Frame: Up to 1.5 years ]
  • Part 2: Number of participants with adverse events by severity [ Time Frame: Up to 1.5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • Part 1: Number of subjects with dose-limiting toxicity (DLT) [ Time Frame: Up to Day 28 ]
  • Part 1: Type of dose-limiting toxicity (DLT) [ Time Frame: Up to Day 28 ]
  • Part 2: Occurence of adverse events and serious adverse events [ Time Frame: Up to 1.5 years ]
  • Part 2: Severity of adverse events and serious adverse events [ Time Frame: Up to 1.5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2020)
  • Part 2: Serum concentration of JNJ-63709178 [ Time Frame: Up to 1.5 years ]
  • Part 2: JNJ-63709178 Receptor occupancy [ Time Frame: Up to 1.5 years ]
  • Part 2: Number of participants with depletion of CD123 expressing cells [ Time Frame: Up to 1.5 years ]
  • Part 2: Systemic cytokine concentration [ Time Frame: Up to 1.5 years ]
  • Part 2: Concentration of markers of T cell activation [ Time Frame: Up to 1.5 years ]
  • Part 2: Anti- JNJ-63709178 antibodies concentration [ Time Frame: Up to 1.5 years ]
  • 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) plus CR with partial hematologic recovery (CRh).
  • 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 CRh, or death due to any cause.
  • Part 2: Relapse-free survival (RFS) [ Time Frame: Up to 1.5 years ]
    RFS is defined as time from CR, CRi, or CRh confirmed objective response to relapse from CR, CRi, or CRh or death from any cause.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • Part 2: Serum concentration of JNJ-63709178 [ Time Frame: Up to 1.5 years ]
  • Part 2: JNJ-63709178 Receptor occupancy [ Time Frame: Up to 1.5 years ]
  • Part 2: Number of subjects with depletion of CD123 expressing cells [ Time Frame: Up to 1.5 years ]
  • Part 2: Systemic cytokine concentration [ Time Frame: Up to 1.5 years ]
  • Part 2: Concentration of markers of T cell activation [ Time Frame: Up to 1.5 years ]
  • Part 2: Anti- JNJ-63709178 antibodies concentration [ Time Frame: Up to 1.5 years ]
  • 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).
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Official Title  ICMJE 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
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.
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 participants with relapsed or refractory acute myeloid leukemia (AML) who are ineligible for or have exhausted standard therapeutic options. The study will be conducted in 2 parts: dose escalation and dose expansion. 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). Participants' safety will be monitored throughout the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia, Myeloid, Acute
Intervention  ICMJE Drug: JNJ-63709178
Participants will receive JNJ-63709178 in Part 1 and Part 2.
Study Arms  ICMJE
  • Experimental: Part 1: Dose Escalation
    Participants will receive JNJ-63709178 in Part 1 (in different cohorts). Each subsequent cohort will receive JNJ-63709178 at an increased dose level. Ascending doses may be given initially to minimize or prevent cytokine release syndrome. Dose escalation will continue until the maximum tolerated dose is reached or all planned doses are administered.
    Intervention: Drug: JNJ-63709178
  • Experimental: Part 2: Dose Expansion
    Participants will receive JNJ-63709178 at the recommended Phase 2 dose(s) (RP2D) determined in dose expansion phase.
    Intervention: Drug: JNJ-63709178
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2019)
120
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2016)
60
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 participant had an allogenic transplant there must be no apparent signs of graft versus host disease and participants must have discontinued all immunosuppressive therapies for at least 4 weeks
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Spain,   United States
Removed Location Countries Australia,   Belgium,   Germany
 
Administrative Information
NCT Number  ICMJE NCT02715011
Other Study ID Numbers  ICMJE CR108147
63709178AML1001 ( Other Identifier: Janssen Research & Development, LLC )
2016-000208-27 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP