N=~220
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Key eligibility criteria*:
- Positive for a CALR driver mutation of essential thrombocytopenia or myelofibrosis
- ECOG PS 0–2
- No concurrent or recent malignancies†
- No prior solid organ transplantation
- No prior ASCT within 6 months of first dose of study treatment
Primary outcomes:
- DLTs
- AEs
Secondary outcomes:
- Serum concentration of JNJ-88549968
- Number of participants with ADAs
- ORR
- CR
- TTR
- DOR
- Part 2‖: Change from baseline in MPN symptom burden
*Not a complete list of inclusion and exclusion criteria. †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 ≥3 years after treatment ended are allowed to enter the study. ‡For US and Canada sites: ruxolitinib will be administered for participants with myelofibrosis only. §For US sites: momelotinib will be administered for participants with myelofibrosis only. ‖Including Part 2b (US only).
Ab, antibody; ADA, anti-drug antibody; AE, adverse event; ASCT, autologous stem cell transplant; CALR, calreticulin; CD, cluster of differentiation; CR, complete response; DLT, dose-limiting toxicity; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; MPN, myeloproliferative neoplasm; ORR, overall response rate; PS, performance status; TTR, time to response.