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

Last Updated   May 14, 2025

Want to learn how to participate in this trial?

88549968MPN1001

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 1
  • Sites
    19 Sites
  • Status
    Recruiting

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).

CONDITIONS

  • Myeloproliferative Disorders
  • Essential Thrombocythemia
  • Cancer
  • Primary Myelofibrosis

ELIGIBILITY


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


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 th

More...

DETAILS

LOCATIONS

Locations in:
United States, France, Germany, Spain, United Kingdom, Canada
Country (6) City or Province (19) Status
United States Duarte City of Hope
RECRUITING
United States Ann Arbor University of Michigan
RECRUITING
United States Charlotte Levine Cancer Institute
RECRUITING
United States Philadelphia University of Pennsylvania
RECRUITING
United States Nashville Sarah Cannon Cancer Institute
RECRUITING
United States Houston MD Anderson Cancer Center
RECRUITING
France Paris Hopital Saint Louis
RECRUITING
France Pierre Benite Cedex CH LYON SUD - Hematology
RECRUITING
Germany Aachen Universitaetsklinikum der RWTH Aachen
RECRUITING
Spain Badalona Hosp. Univ. Germans Trias I Pujol
RECRUITING
Spain Valencia Hosp. Clinico Univ. de Valencia
RECRUITING
United Kingdom London University College London Hospitals Nhs Foundation Trust
RECRUITING
United Kingdom Oxford Churchill Hospital
RECRUITING
United States Tampa Moffit Cancer center
RECRUITING
United States New York Memorial Sloan Kettering Cancer Center
RECRUITING
Canada Toronto Princess Margaret Cancer Centre University Health Network
RECRUITING
Germany Berlin Charite Campus Benjamin Franklin
RECRUITING
Germany Hannover Medizinische Hochschule Hannover
RECRUITING
Germany Regensburg Universitaetsklinikum Regensburg
RECRUITING
Show More
Geo Locations

34.13945, -117.97729

42.27756, -83.74088

35.22709, -80.84313

39.95233, -75.16379

36.16589, -86.78444

29.76328, -95.36327

48.85341, 2.3488

45.7009, 4.82511

50.77664, 6.08342

41.45004, 2.24741

39.46975, -0.37739

51.50853, -0.12574

51.75222, -1.25596

27.94752, -82.45843

40.71427, -74.00597

43.70011, -79.4163

52.52437, 13.41053

52.37052, 9.73322

49.01513, 12.10161

x
50

Indicates 50+ sites in this region: click to zoom in.

10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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