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Trial record 1 of 1 for:    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
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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 : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential 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 4, 2022


Arm Intervention/treatment
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.
Drug: JNJ-63709178
Participants will receive JNJ-63709178 in Part 1 and Part 2.

Experimental: Part 2: Dose Expansion
Participants will receive JNJ-63709178 at the recommended Phase 2 dose(s) (RP2D) determined in dose expansion phase.
Drug: JNJ-63709178
Participants will receive JNJ-63709178 in Part 1 and Part 2.




Primary Outcome Measures :
  1. Part 1: Number of participants 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: Number of participants with adverse events and serious adverse events [ Time Frame: Up to 1.5 years ]
  4. Part 2: Number of participants with adverse events by severity [ 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 participants 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) plus CR with partial hematologic recovery (CRh).

  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 CRh, 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, CRi, or CRh confirmed objective response to relapse from CR, CRi, or CRh or death from any cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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

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
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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
Show Show 17 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02715011    
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: April 24, 2020
Last Verified: April 2020

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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:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms