88549968MPN1001
Research type
Research Study
Full 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
IRAS ID
1008190
Contact name
Florence Baluwa
Contact email
Sponsor organisation
Janssen Global Clinical Operations, Janssen Research & Development
ISRCTN Number
ISRCTN79300015
Clinicaltrials.gov Identifier
Research summary
Myeloproliferative neoplasms are rare blood cancers causing abnormal blood cell growth in bone marrow. Essential thrombocythaemia is a myeloproliferative neoplasms where overproduction of platelets raises clotting, bleeding, marrow damage and leukaemia risk. Myelofibrosis involves bone marrow damage, low blood counts and enlarged spleen. Myeloproliferative neoplasms may cause blood clots, heart attacks due to blood cell overproduction and infection due to impaired blood cell function. Essential thrombocythaemia and myelofibrosis may progress to leukaemia (severe uncontrolled blood cancer).
JNJ-88549968 (study drug) targets CD3 marker on T lymphocytes (immune cells) and mutated calreticulin target (CALRmut) on myeloproliferative neoplasm cells. The drug brings the target cells to the immune cells to clear the cancer cells.
The aim of the study is to assess the safety profile of JNJ-88549968 in Part 1 and further assess safety in the context of an effective dose in Part 2.
Adults with calreticulin mutations in myeloproliferative neoplasms diagnosed as essential thrombocythaemia or myelofibrosis.
The Study has 2 parts:
Part 1 (Dose Escalation): Participants will get JNJ-88549968 to find effective dose and schedule. This will be determined by assessing its safety, how the body processes it (pharmacokinetics), how it affects the body (pharmacodynamics) and its initial effectiveness in different dosing regimens.Part 2 (Cohort Expansion): Participants will get JNJ-88549968 at determined effective dose from Part 1. Regular safety and efficacy reviews will be conducted.
Safety assessments involves physical examination, vital signs, clinical laboratory tests, Eastern Co-operative Oncology Group performance status (ECOG)*, electrocardiograms of the heart and adverse event monitoring.
* ECOG measures how well participants can take care of themselves.
Total study duration will be approximately 2 years
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
23/EE/0239
Date of REC Opinion
8 Dec 2023
REC opinion
Further Information Favourable Opinion