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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

Sponsor: Janssen Research & Development, LLC · Participants: 300 · Started: Dec 20, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06150157

Locations in the U.S.

CaliforniaCity of Hope, Duarte
ColoradoUCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center, Aurora
FloridaMoffit Cancer center, Tampa
GeorgiaEmory University, Atlanta
MichiganUniversity of Michigan, Ann Arbor
Start Midwest, Grand Rapids
New JerseySTART New Jersey, East Brunswick
Rutgers Cancer Institute of New Jersey, New Brunswick
New YorkMemorial Sloan Kettering Cancer Center, New York
Montefiore Medical Center, The Bronx
North CarolinaLevine Cancer Institute, Charlotte
PennsylvaniaUniversity of Pennsylvania, Philadelphia
South CarolinaPrisma Health, Greenville
TennesseeSarah Cannon Cancer Institute, Nashville
TexasMD Anderson Cancer Center, Houston
WashingtonSwedish Cancer Institute, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.