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

Janssen Research & Development, LLC0 个研究点目标入组 100 人开始时间: 2023年12月15日最近更新: 2024年4月22日

适应症

试验速览

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•Each potential participant must satisfy all of the following criteria to be enrolled in the study:
•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. Have received prior therapy(ies): ET: At least 2 lines of prior cytoreductive therapy, at least 1 of which must have been hydroxyurea (HU); MF: At least 1 prior JAK inhibitor (JAKi) therapy unless ineligible
•4. Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of less than or equal to (<=) 2
•5. Have the following clinical hematology laboratory values pre-dose:
•5.1. Hemoglobin >=8.0 grams per deciliter (g/dL)
•5.2. Neutrophils >=0.75*10^9 per liter (/L) without the assistance of granulocyte growth factors within 4 weeks of the first dose of the study drug
•5.3. Platelets >=50*10^9/L without the assistance of thrombopoietic factors or transfusions

•Any potential participant who meets any of the following criteria will be excluded from participating in the study:
•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 the 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- Either of the following regarding hematopoietic stem cell transplantation:
•3.1. Prior treatment with allogenic stem cell transplant less than or equal to (<=) 6 months before the first dose of JNJ-88549968 or
•3.2. Evidence of graft versus host disease (GVHD) that requires immunosuppressant therapy
•4. History of clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment

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