NCT06150157

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

A First-in-Human Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-88549968, a T-cell Redirecting Bispecific Antibody for CALR-mutated Myeloproliferative Neoplasms

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). 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

• Neoplasms

Interventions

Type	Name	Description
DRUG	JNJ-88549968	JNJ-88549968 will be administered.
DRUG	Ruxolitinib	For US sites: Ruxolitinib will be administered for participants with MF only.
DRUG	Momelotinib	For US sites: Momelotinib will be administered for participants with MF only.

Timeline

• Start date: 2023-12-20
• Primary completion: 2026-12-04
• Completion: 2028-04-12
• First posted: 2023-11-29
• Last updated: 2026-04-14

Locations

31 sites across 8 countries: United States, Canada, France, Germany, Israel, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study