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Leukemia, Myeloid, AcutePhase 1NCT02715011

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

A Phase 1 study testing JNJ-63709178 in people with Leukemia, Myeloid, Acute, run by Janssen Research & Development, LLC at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
JNJ-63709178
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
10 sitesin 2 countries
Study dates
1 Jun 2016to 26 Mar 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

United States7 sites

  • Study site

    Charlotte, North Carolina

  • Study site

    Detroit, Michigan

  • Study site

    Houston, Texas

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

Other trials in United States

Spain3 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Seville

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
JNJ-63709178
Keywords
Leukemia, Myeloid, Acute, JNJ-63709178
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-63709178Drug

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

Study groups in NCT02715011
Study groupRoleWhat they receive
Part 1: Dose EscalationExperimentalParticipants 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.
Receives: Drug: JNJ-63709178
Part 2: Dose ExpansionExperimentalParticipants will receive JNJ-63709178 at the recommended Phase 2 dose(s) (RP2D) determined in dose expansion phase.
Receives: Drug: JNJ-63709178

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of participants with dose-limiting toxicity (DLT)

    Measured: Up to Day 28

  2. Part 1: Type of dose-limiting toxicity (DLT)

    Measured: Up to Day 28

  3. Part 2: Number of participants with adverse events and serious adverse events

    Measured: Up to 1.5 years

  4. Part 2: Number of participants with adverse events by severity

    Measured: Up to 1.5 years

Secondary outcomes (9)

  1. Part 2: Serum concentration of JNJ-63709178

    Measured: Up to 1.5 years

  2. Part 2: JNJ-63709178 Receptor occupancy

    Measured: Up to 1.5 years

  3. Part 2: Number of participants with depletion of CD123 expressing cells

    Measured: Up to 1.5 years

  4. Part 2: Systemic cytokine concentration

    Measured: Up to 1.5 years

  5. Part 2: Concentration of markers of T cell activation

    Measured: Up to 1.5 years

  6. Part 2: Anti- JNJ-63709178 antibodies concentration

    Measured: Up to 1.5 years

  7. 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).

    Measured: Up to 1.5 years

  8. 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.

    Measured: Up to 1.5 years

  9. 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.

    Measured: Up to 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2016 (estimated)
  2. Study start1 Jun 2016
  3. Primary completion26 Mar 2021
  4. Study completion26 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02715011
Sponsor's protocol ID
CR108147
Other IDs
63709178AML1001, 2016-000208-27, 2016
Status last verified
Aug 2021
First submitted
16 Mar 2016
Last updated
31 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-63709178 in people with Leukemia, Myeloid, Acute, run by Janssen Research & Development, LLC at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of participants with dose-limiting toxicity (DLT) (time frame: Up to Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02715011.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.

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