A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
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
- Neoplasms
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 300
- Started
- 20 December 2023
- Main results due
- 4 December 2026
- Study sites
- 44
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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 * For US sites: Eligible for ruxolitinib therapy as per drug label for participants naive to a janus kinase (JAK) inhibitor 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
What this study is about
In the sponsor’s own words, from the registry.
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). For U.S. sites: the purpose of this study is to characterize the safety and to determine the RP2D(s) and optimal dosing schedule(s) of JNJ-88549968 in Part 1 and part 1b (Dose Escalation), and to characterize the safety of JNJ-88549968 at the RP2D(s) in Part 2 and part 2b (Cohort Expansion), when given as monotherapy in essential thrombocythemia (ET) or myelofibrosis (MF), and with ruxolitinib or momelotinib in MF only.
Study sites(44)
City of Hope
Duarte, California, United States
Recruiting
UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center
Aurora, Colorado, United States
Recruiting
Moffit Cancer center
Tampa, Florida, United States
Recruiting
Emory University
Atlanta, Georgia, United States
Recruiting
University of Michigan
Ann Arbor, Michigan, United States
Recruiting
Start Midwest
Grand Rapids, Michigan, United States
Recruiting
START New Jersey
East Brunswick, New Jersey, United States
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
Montefiore Medical Center
The Bronx, New York, United States
Recruiting
Levine Cancer Institute
Charlotte, North Carolina, United States
Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Recruiting
Prisma Health
Greenville, South Carolina, United States
Recruiting
Sarah Cannon Cancer Institute
Nashville, Tennessee, United States
Recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
Swedish Cancer Institute
Seattle, Washington, United States
Recruiting
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Recruiting
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada
Recruiting
Jewish General Hospital
Montreal, Quebec, Canada
Recruiting
Peking Union Medical College Hospital
Beijing, China
Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Recruiting
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
Recruiting
Hopital Saint Louis
Paris, France
Recruiting
CH LYON SUD - Hematology
Pierre-Bénite, France
Recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France
Recruiting
Universitaetsklinikum der RWTH Aachen
Aachen, Germany
Recruiting
Charite Campus Benjamin Franklin
Berlin, Germany
Recruiting
Med. Universitatsklinik Essen
Essen, Germany
Recruiting
Medizinische Hochschule Hannover
Hanover, Germany
Recruiting
Universitaetsklinikum Heidelberg
Heidelberg, Germany
Recruiting
Universitaetsklinikum Regensburg
Regensburg, Germany
Recruiting
Carmel Medical Center
Haifa, Israel
Recruiting
Hadassah University Hospita Ein Kerem
Jerusalem, Israel
Recruiting
Sheba Medical Center
Ramat Gan, Israel
Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Recruiting
Policlinico Sant'Orsola Malpighi
Bologna, Italy
Recruiting
Policlinico di Milano
Milan, Italy
Recruiting
Juntendo University Hospital
Bunkyō City, Japan
Recruiting
National Cancer Center Hospital East
Kashiwa, Japan
Recruiting
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain
Recruiting
Hosp. Clinico Univ. de Valencia
Valencia, Spain
Recruiting
University College London Hospitals Nhs Foundation Trust
London, United Kingdom
Recruiting
Guy's and St Thomas' Hospital
London, United Kingdom
Recruiting
Churchill Hospital
Oxford, United Kingdom
Recruiting
Showing 44 of 44 sites. 44 of the 44 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06150157. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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