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

NCT ID: NCT02715011

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2021-03-26

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.

Conditions

Leukemia, Myeloid, Acute

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

JNJ-63709178

Intervention Type: DRUG

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

Part 2: Dose Expansion

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

Group Type: EXPERIMENTAL

JNJ-63709178

Intervention Type: DRUG

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

Interventions

JNJ-63709178

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Detroit, Michigan, United States

New York, New York, United States

Charlotte, North Carolina, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Nashville, Tennessee, United States

Houston, Texas, United States

Barcelona, , Spain

Madrid, , Spain

Seville, , Spain

Countries

United States; Spain

Other Identifiers

63709178AML1001

Identifier Type: OTHER

Identifier Source: secondary_id

2016-000208-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108147

Identifier Type: -

Identifier Source: org_study_id