Actively Recruiting
A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
Led by Janssen Research & Development, LLC · Updated on 2026-05-12
220
Participants Needed
31
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years or older (or the legal age of majority where the study takes place)
- Have a positive CALR driver mutation in essential thrombocythemia (ET) or myelofibrosis (MF)
- Meet risk characteristics for ET or MF as described in the study protocol
- Have an ECOG performance status of 2 or less
- For US participants naive to a JAK inhibitor, be eligible for ruxolitinib therapy per drug label
You will not qualify if you...
- Known allergies or intolerance to ingredients of the study treatment
- Have current or recent other cancers except certain skin cancers, cervical carcinoma in situ, or cancers considered cured or with minimal recurrence risk within 1 year
- Prior solid organ transplant
- Prior allogenic stem cell transplant within 6 months before first dose or active graft versus host disease needing immunosuppressants
- History of significant cardiovascular disease within 6 months before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Moffit Cancer center
Tampa, Florida, United States, 33612
Actively Recruiting
4
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
6
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
7
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
8
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Sarah Cannon Cancer Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
11
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
12
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
13
Hopital Saint Louis
Paris, France, 75475
Actively Recruiting
14
CH LYON SUD - Hematology
Pierre-Bénite, France, 69495
Actively Recruiting
15
Universitaetsklinikum der RWTH Aachen
Aachen, Germany, 52074
Actively Recruiting
16
Charite Campus Benjamin Franklin
Berlin, Germany, 12203
Actively Recruiting
17
Med. Universitatsklinik Essen
Essen, Germany, 45147
Actively Recruiting
18
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
19
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
20
Universitaetsklinikum Regensburg
Regensburg, Germany, 93053
Actively Recruiting
21
Carmel Medical Center
Haifa, Israel, 3436212
Actively Recruiting
22
Hadassah University Hospita Ein Kerem
Jerusalem, Israel, 9112001
Actively Recruiting
23
Sheba Medical Center
Ramat Gan, Israel, 5266202
Actively Recruiting
24
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
25
Policlinico Sant'Orsola Malpighi
Bologna, Italy, 40138
Actively Recruiting
26
Policlinico di Milano
Milan, Italy, 21022
Actively Recruiting
27
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain, 08916
Actively Recruiting
28
Hosp. Clinico Univ. de Valencia
Valencia, Spain, 46010
Actively Recruiting
29
University College London Hospitals Nhs Foundation Trust
London, United Kingdom, NW1 2PG
Actively Recruiting
30
Guy's and St Thomas' Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
31
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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