- A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms — Recruiting • Phase I • Oncology • NCT06150157.
- Drug Being Tested: JNJ-88549968, a novel therapeutic agent targeting CALR-mutated myeloproliferative neoplasms (MPNs), with the study establishing safety profile, recommended phase 2 dose, and optimal dosing schedules through dose escalation and expansion phases.
- Patient Eligibility Overview: Adults with confirmed CALR-mutated MPNs (including essential thrombocythemia, polycythemia vera, or primary myelofibrosis) who meet defined haematological and organ function criteria, excluding those with prior or active malignancies or significant comorbidities.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- : * 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 (
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.