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Looking for participantsPhase1

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

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT06150157

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
JNJ-88549968 (drug), Ruxolitinib (drug), Momelotinib (drug)
How long the study runs
Study runs about 54 months (dates as stated)
About the drug or intervention
JNJ-88549968 — drug: JNJ-88549968 will be administered. · Ruxolitinib — drug: For US sites: Ruxolitinib will be administered for participants with MF only. · Momelotinib — drug: For US sites: Momelotinib will be administered for participants with MF only.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
300
Started
2023-12-20
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for neoplasms
  • • Phase1 - 300 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with neoplasms

Where?

  • • London - University College London Hospitals Nhs Foundation Trust
  • • London - Guy's and St Thomas' Hospital
  • • Oxford - Churchill Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Neoplasms

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Be greater than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the...
  • ✓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 activity scale (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)...

Who cannot take part

  • ✗Known allergies, hypersensitivity, or intolerance to the excipients of the study treatment
  • ✗Prior solid organ transplantation
  • ✗Either of the following regarding hematopoietic stem cell transplantation:
  • ✗Prior treatment with allogenic stem cell transplant less than or equal to (\<=) 6 months before the first dose of...
  • ✗Evidence of graft versus host disease (GVHD) that requires immunosuppressant therapy
See the full 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

Where Is This Study? (3 UK sites)

University College London Hospitals Nhs Foundation Trust

London NW1 2PG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Guy's and St Thomas' Hospital

London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Churchill Hospital

Oxford OX3 7LE, United Kingdom

Recruiting

How to Get in Touch

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09