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Recruiting NCT06150157

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms

Phase I Interventional Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JNJ-88549968, Ruxolitinib, Momelotinib.
Who it may be relevant to
Registry conditions: Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, China, France, Germany +5
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A First-in-Human Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-88549968, a T-cell Redirecting Bispecific Antibody for CALR-mutated Myeloproliferative Neoplasms

Overview

The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D\[s\]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S. sites: the purpose of this study is to characterize the safety and to determine the RP2D(s) and optimal dosing schedule(s) of JNJ-88549968 in Part 1 and part 1b (Dose Escalation), and to characterize the safety of JNJ-88549968 at the RP2D(s) in Part 2 and part 2b (Cohort Expansion), when given as monotherapy in essential thrombocythemia (ET) or myelofibrosis (MF), and with ruxolitinib or momelotinib in MF only.

Interventions

  • Drug JNJ-88549968
    JNJ-88549968 will be administered.
  • Drug Ruxolitinib
    For US sites: Ruxolitinib will be administered for participants with MF only.
  • Drug Momelotinib
    For US sites: Momelotinib will be administered for participants with MF only.

Primary outcome measures

  • Part 1, Part 1b (US Only): Number of Participants With Dose Limiting Toxicity (DLT) [Time frame: Approximately up to 35 days after first dose of study treatment]
  • Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs) [Time frame: Up to 2 years]
  • Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs) by Severity [Time frame: Up to 2 years]
Secondary outcome measures (7)
  • Part 1, 2, Part 1b (US Only), Part 2b (US Only): Serum Concentration of JNJ-88549968 [Time frame: Up to 2 years]
  • Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants With Presence of Anti-Drug Antibodies to JNJ-88549968 [Time frame: Up to 2 years]
  • Part 1, 2, Part 1b (US Only), Part 2b (US Only): Overall Response Rate [Time frame: Up to 2 years]
  • Part 1, 2, Part 1b (US Only), Part 2b (US Only): Complete Response (CR) Rate [Time frame: Up to 2 years]
  • Part 1, 2, Part 1b (US Only), Part 2b (US Only): Time to Response (TTR) [Time frame: Up to 2 years]
  • Part 1, 2, Part 1b (US Only), Part 2b (US Only): Duration of Response (DOR) [Time frame: Up to 2 years]
  • Part 2, Part 2b (US Only): Change From Baseline in Myeloproliferative Neoplasm (MPN) Symptom Burden [Time frame: Baseline up to 2 years]

Eligibility criteria

Inclusion criteria

  • Be greater than or equal to (>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever the greater) at the time of informed consent
  • Positive for a calreticulin (CALR) driver mutation of essential thrombocythemia (ET) or myelofibrosis (MF)
  • Participants with ET and MF with risk characteristics as described in the protocol
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of less than or equal to (<=) 2
  • For US sites: Eligible for ruxolitinib therapy as per drug label for participants naive to a janus kinase (JAK) inhibitor

Exclusion criteria

  • Known allergies, hypersensitivity, or intolerance to the excipients of the study treatment
  • Concurrent or recently diagnosed or treated malignancies present at the time of participant screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix, and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of study treatment in the opinion of both the investigator and sponsor's medical monitor. Participants cured of another malignant disease with no sign of relapse greater than or equal to (>=) 3 years after treatment ended are allowed to enter the study
  • Prior solid organ transplantation
  • Either of the following regarding hematopoietic stem cell transplantation:
  • Prior treatment with allogenic stem cell transplant less than or equal to (<=) 6 months before the first dose of JNJ-88549968 or
  • Evidence of graft versus host disease (GVHD) that requires immunosuppressant therapy
  • History of clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 13 centers
  • City of Hope — Duarte
  • UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center — Aurora
  • Moffit Cancer center — Tampa
  • Emory University — Atlanta
  • University of Michigan — Ann Arbor
  • Start Midwest — Grand Rapids
  • START New Jersey — East Brunswick
  • Memorial Sloan Kettering Cancer Center — New York
  • … and 5 more centers
Germany · 6 centers
  • Universitaetsklinikum der RWTH Aachen — Aachen
  • Charite Campus Benjamin Franklin — Berlin
  • Med. Universitatsklinik Essen — Essen
  • Medizinische Hochschule Hannover — Hanover
  • Universitaetsklinikum Heidelberg — Heidelberg
  • Universitaetsklinikum Regensburg — Regensburg
Israel · 4 centers
  • Carmel Medical Center — Haifa
  • Hadassah University Hospita Ein Kerem — Jerusalem
  • Sheba Medical Center — Ramat Gan
  • Tel Aviv Sourasky Medical Center — Tel Aviv
France · 3 centers
  • Hopital Saint Louis — Paris
  • CH LYON SUD - Hematology — Pierre-Bénite
  • Institut Universitaire du Cancer Toulouse Oncopole — Toulouse
United Kingdom · 3 centers
  • University College London Hospitals Nhs Foundation Trust — London
  • Guy's and St Thomas' Hospital — London
  • Churchill Hospital — Oxford
Canada · 2 centers
  • Princess Margaret Cancer Centre University Health Network — Toronto
  • Jewish General Hospital — Montreal
China · 2 centers
  • Peking Union Medical College Hospital — Beijing
  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin
Italy · 2 centers
  • Policlinico Sant'Orsola Malpighi — Bologna
  • Policlinico di Milano — Milan
Japan · 2 centers
  • Juntendo University Hospital — Bunkyō City
  • National Cancer Center Hospital East — Kashiwa
Spain · 2 centers
  • Hosp. Univ. Germans Trias I Pujol — Badalona
  • Hosp. Clinico Univ. de Valencia — Valencia

Identifiers

NCT: NCT06150157 · 88549968MPN1001 · 2023-505584-36-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗