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NCT06150157 | RECRUITING | Myeloproliferative Disorders

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
Sponsor:

Janssen Research & Development, LLC

Brief Summary:

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).

Condition or disease

Myeloproliferative Disorders

Essential Thrombocythemia

Neoplasms

Myelofibrosis

Intervention/treatment

JNJ-88549968

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official 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
Actual Study Start Date : 2023-12-20
Estimated Primary Completion Date : 2026-12-04
Estimated Study Completion Date : 2026-12-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
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
A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms

Location Details

NCT06150157

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

City of Hope

Duarte, California, United States, 91010

RECRUITING

United States, Florida

Moffit Cancer center

Tampa, Florida, United States, 33612

RECRUITING

United States, Road cancer

University of Michigan

Ann Arbor, Road cancer, United States, 48109

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, North Carolina

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

RECRUITING

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Tennessee

Sarah Cannon Cancer Institute

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

Canada, Ontario

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, Canada, M5G 1Z5

RECRUITING

France,

Saint Louis hospital

Paris, France, 75475

RECRUITING

France,

CH LYON SUD - Hematology

Pierre Benite Cedex, France, 69495

RECRUITING

Germany,

University Clinic of RWTH Aachen

Aachen, Germany, 52074

RECRUITING

Germany,

Charite Campus Benjamin Franklin

Berlin, Germany, 12203

RECRUITING

Germany,

Medical University of Hanover

Hannover, Germany, 30625

RECRUITING

Germany,

Universitaetskinic Regensburg

Regensburg, Germany, 93053

RECRUITING

Israel,

Carmel Medical Center

Haifa, Israel, 3436212

RECRUITING

Israel,

Hadassah University Hospital Ein Kerem

Jerusalem, Israel, 9112001

RECRUITING

Israel,

Sheba Medical Center

Ramat Gain, Israel, 5266202

RECRUITING

Israel,

Tel Aviv Sourasky Medical Center

Tel Aviv Yafo, Israel, 64239

RECRUITING

Spain,

Hosp. Univ. Brothers Trias and Pujol

Badalona, Spain, 08916

RECRUITING

Spain,

Hospital. Clinic Univ. Of Valencia

Valencia, Spain, 46010

RECRUITING

United Kingdom,

University College London Hospitals Nhs Foundation Trust

London, United Kingdom, NW1 2PG

RECRUITING

United Kingdom,

Churchill Hospital

Oxford, United Kingdom, As a solution