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



Status:Recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:June 1, 2016
End Date:August 17, 2021
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:
Email:JNJ.CT@sylogent.com

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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

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.

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 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.

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
We found this trial at
15
sites
119-129 Passeig de la Vall d'Hebron
Barcelona, 08035
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Barcelona,
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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Aurora, Colorado 80045
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Aurora, CO
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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1021 Morehead Medical Drive
Charlotte, North Carolina 28204
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Charlotte, NC
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Duarte, California 91010
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Duarte, CA
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Pittsburgh, PA
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