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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.

Primary Objectives:
Part 1(Dose Escalation) To characterize safety and to determine the putative RP2D(s) and optimal dosing schedule(s) of JNJ-88549968in monotherapy (ET and MF) and in combination with ruxolitinibor momelotinib(MF only)

Part 2(Cohort Expansion) To further characterize the safety of JNJ-88549968 at the putative RP2D(s) in monotherapy (ET and MF) and in combination with ruxolitinibor momelotinib(MF only)

Secondary Objectives:
- To characterize the PK of JNJ-88549968

- To assess the immunogenicity of JNJ-88549968

- Evaluate the preliminary clinical activity of JNJ-88549968 in monotherapy (ET and MF) and in combination with ruxolitinib or momelotinib (MF only)

Protocol Number: 022608
Phase: Phase I
Applicable Disease Sites: Myeloid and Monocytic Leukemia
Drugs Involved: JNJ-88549968
Momelotinib
Ruxolitinib
Principal Investigator: Neil Palmisiano
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria ►

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.