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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)

Primary Purpose

Leukemia, Myeloid, Acute

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
JNJ-63709178
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring Leukemia, Myeloid, Acute, JNJ-63709178

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1: Dose Escalation

Part 2: Dose Expansion

Arm Description

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.

Participants will receive JNJ-63709178 at the recommended Phase 2 dose(s) (RP2D) determined in dose expansion phase.

Outcomes

Primary Outcome Measures

Part 1: Number of participants with dose-limiting toxicity (DLT)
Part 1: Type of dose-limiting toxicity (DLT)
Part 2: Number of participants with adverse events and serious adverse events
Part 2: Number of participants with adverse events by severity

Secondary Outcome Measures

Part 2: Serum concentration of JNJ-63709178
Part 2: JNJ-63709178 Receptor occupancy
Part 2: Number of participants with depletion of CD123 expressing cells
Part 2: Systemic cytokine concentration
Part 2: Concentration of markers of T cell activation
Part 2: Anti- JNJ-63709178 antibodies concentration
Part 2: Overall response rate (ORR)
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)
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)
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.

Full Information

First Posted
March 16, 2016
Last Updated
August 30, 2021
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02715011
Brief Title
Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
March 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute
Keywords
Leukemia, Myeloid, Acute, JNJ-63709178

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Dose Escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2: Dose Expansion
Arm Type
Experimental
Arm Description
Participants will receive JNJ-63709178 at the recommended Phase 2 dose(s) (RP2D) determined in dose expansion phase.
Intervention Type
Drug
Intervention Name(s)
JNJ-63709178
Intervention Description
Participants will receive JNJ-63709178 in Part 1 and Part 2.
Primary Outcome Measure Information:
Title
Part 1: Number of participants with dose-limiting toxicity (DLT)
Time Frame
Up to Day 28
Title
Part 1: Type of dose-limiting toxicity (DLT)
Time Frame
Up to Day 28
Title
Part 2: Number of participants with adverse events and serious adverse events
Time Frame
Up to 1.5 years
Title
Part 2: Number of participants with adverse events by severity
Time Frame
Up to 1.5 years
Secondary Outcome Measure Information:
Title
Part 2: Serum concentration of JNJ-63709178
Time Frame
Up to 1.5 years
Title
Part 2: JNJ-63709178 Receptor occupancy
Time Frame
Up to 1.5 years
Title
Part 2: Number of participants with depletion of CD123 expressing cells
Time Frame
Up to 1.5 years
Title
Part 2: Systemic cytokine concentration
Time Frame
Up to 1.5 years
Title
Part 2: Concentration of markers of T cell activation
Time Frame
Up to 1.5 years
Title
Part 2: Anti- JNJ-63709178 antibodies concentration
Time Frame
Up to 1.5 years
Title
Part 2: Overall response rate (ORR)
Description
ORR rate is defined as the rate of complete response (CR) plus CR with incomplete recovery (CRi) plus CR with partial hematologic recovery (CRh).
Time Frame
Up to 1.5 years
Title
Part 2: Event-free survival (EFS)
Description
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.
Time Frame
Up to 1.5 years
Title
Part 2: Relapse-free survival (RFS)
Description
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.
Time Frame
Up to 1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Detroit
State/Province
Michigan
Country
United States
City
New York
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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