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NCT Number: NCT02715011

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

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.

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Key information

Conditions

Leukemia, Myeloid, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-63709178

Drug

Participants will receive JNJ-63709178 in Part 1 and Part 2.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2016
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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