RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2023-12-20
Study Completion:2026-11-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06150157

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Positive for a calreticulin (CALR) driver mutation of essential thrombocythemia (ET) or myelofibrosis (MF)
  3. * Participants with ET and MF with risk characteristics as described in the protocol
  4. * Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of less than or equal to (\<=) 2
  1. * Known allergies, hypersensitivity, or intolerance to the excipients of the study treatment
  2. * 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
  3. * Prior solid organ transplantation
  4. * Either of the following regarding hematopoietic stem cell transplantation:
  5. 1. Prior treatment with allogenic stem cell transplant less than or equal to (\<=) 6 months before the first dose of JNJ-88549968 or
  6. 2. Evidence of graft versus host disease (GVHD) that requires immunosuppressant therapy
  7. * History of clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment

Contacts and Locations

Study Contact

Study Contact
CONTACT
844-434-4210
Participate-In-This-Study@its.jnj.com

Principal Investigator

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

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Levine Cancer Institute
Charlotte, North Carolina, 28204
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Sarah Cannon Cancer Institute
Nashville, Tennessee, 37203
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-20
Study Completion Date2026-11-19

Study Record Updates

Study Start Date2023-12-20
Study Completion Date2026-11-19

Terms related to this study

Additional Relevant MeSH Terms

  • Myeloproliferative Disorders
  • Essential Thrombocythemia
  • Neoplasms
  • Myelofibrosis