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

Description

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).

Conditions

Myeloproliferative Disorders, Essential Thrombocythemia, Neoplasms, Myelofibrosis

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Study Overview

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Study Details

Study 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).

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

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

Condition
Myeloproliferative Disorders
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope, Duarte, California, United States, 91010

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Charlotte

Levine Cancer Institute, Charlotte, North Carolina, United States, 28204

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Nashville

Sarah Cannon Cancer Institute, Nashville, Tennessee, United States, 37203

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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:
  • 1. Prior treatment with allogenic stem cell transplant less than or equal to (\<=) 6 months before the first dose of JNJ-88549968 or
  • 2. 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2026-11-19