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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


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).

Trial Eligibility

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 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: 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

Study Info

Organization

Janssen Research & Development, LLC


Primary Outcome

Part 1: Number of Participants With Dose Limiting Toxicity (DLT)


Outcome Timeframe Approximately up to 35 days after first dose of study treatment

NCTID NCT06150157

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2023-12-20

Completion Date 2025-10-01

Enrollment Target 100

Interventions

DRUG JNJ-88549968

Locations Recruiting

City of Hope

United States, California, Duarte


University of Michigan

United States, Michigan, Ann Arbor


Levine Cancer Institute

United States, North Carolina, Charlotte


University of Pennsylvania

United States, Pennsylvania, Philadelphia


Sarah Cannon Cancer Institute

United States, Tennessee, Nashville


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