> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-jnj-88549968-for-the-treatment-of-calreticulin-ba23876c-8a4f-4f22-9a4b-adfedd20019f > Record changed: 2026-10-13 # A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms NCT06150157 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) Participants 241 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) Lead sponsor Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) Start date 2023-12-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) Number of sites 39 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Short title** A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) ## Dates **Completion date** 2028-06-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **First posted** 2023-11-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Registry last updated** 2026-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Primary completion date** 2026-12-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Start date** 2023-12-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) ## Size and sites **Participants** 241 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Planned participants** 241 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Number of sites** 39 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Lead sponsor** Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) ## Identifiers **Registry ID** NCT06150157 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **ClinicalTrials.gov ID** NCT06150157 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) ## Study design **Allocation** Not applicable **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) ## Outcomes ### Primary outcomes 1. Part 1, Part 1b (US Only): Number of Participants With Dose Limiting Toxicity (DLT) Timeframe: Approximately up to 35 days after first dose of study treatment Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. For US only: A DLT is any adverse event attributed to study treatment that meets the criteria for severity and duration and that occurs during the evaluation periods unless it can be incontrovertibly attributed to disease or other extraneous cause such as an accident. 2. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs) Timeframe: Up to 2 years An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 3. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs) by Severity Timeframe: Up to 2 years An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0\. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event. Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events \\\[ICANS\\\]) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. ### Secondary outcomes 1. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Serum Concentration of JNJ-88549968 Timeframe: Up to 2 years Serum samples will be analyzed to determine concentrations of JNJ-88549968. 2. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants With Presence of Anti-Drug Antibodies to JNJ-88549968 Timeframe: Up to 2 years Number of participants with presence of anti-drug antibodies to JNJ-88549968 will be reported. 3. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Overall Response Rate Timeframe: Up to 2 years ORR is defined as the percentage of participants who achieve partial response (PR) and complete response (CR) according to modified International Working Group-Myeloproliferative Neoplasm Research and Treatment (IWG-MRT) criteria and modified European Leukemia Net (ELN) consensus report. 4. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Complete Response (CR) Rate Timeframe: Up to 2 years CR rate is defined as the percentage of participants who achieve a best response of CR according to disease as defined in modified IWG-MRT criteria and modified ELN consensus report. 5. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Time to Response (TTR) Timeframe: Up to 2 years TTR is defined for participants who achieved PR or CR as the time from the first dose of study treatment to first response of PR or CR according to modified IWG-MRT criteria and modified ELN consensus report. 6. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Duration of Response (DOR) Timeframe: Up to 2 years DOR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of first documented evidence of disease progression, as defined in modified IWG-MRT criteria and modified ELN consensus report, or death, whichever comes first. 7. Part 2, Part 2b (US Only): Change From Baseline in Myeloproliferative Neoplasm (MPN) Symptom Burden Timeframe: Baseline up to 2 years Change from baseline in MPN symptom burden assessed using patient reported outcome (PRO) questionnaire will be reported in this outcome measure. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) ## Sites - City of HopeDuarte, United StatesRecruiting - UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer CenterAurora, United StatesRecruiting - Moffit Cancer centerTampa, United StatesRecruiting - Emory UniversityAtlanta, United StatesRecruiting - University of MichiganAnn Arbor, United StatesRecruiting - Start MidwestGrand Rapids, United StatesRecruiting - START New JerseyEast Brunswick, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - Montefiore Medical CenterThe Bronx, United StatesRecruiting - Levine Cancer InstituteCharlotte, United StatesRecruiting - University of PennsylvaniaPhiladelphia, United StatesRecruiting - Sarah Cannon Cancer InstituteNashville, United StatesRecruiting - MD Anderson Cancer CenterHouston, United StatesRecruiting - Princess Margaret Cancer Centre University Health NetworkToronto, CanadaRecruiting - Jewish General HospitalMontreal, CanadaRecruiting - Peking Union Medical College HospitalBeijing, ChinaRecruiting - Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesTianjin, ChinaRecruiting - Hopital Saint LouisParis, FranceRecruiting - CH LYON SUD - HematologyPierre-Bénite, FranceRecruiting - Institut Universitaire du Cancer Toulouse OncopoleToulouse, FranceRecruiting - Universitaetsklinikum der RWTH AachenAachen, GermanyRecruiting - Charite Campus Benjamin FranklinBerlin, GermanyRecruiting - Med. Universitatsklinik EssenEssen, GermanyRecruiting - Medizinische Hochschule HannoverHanover, GermanyRecruiting - Universitaetsklinikum HeidelbergHeidelberg, GermanyRecruiting And 14 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) ## References ### Other registry identifiers (2) - 2023 - 2023-505584-36-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06150157) ## Related records ### Drugs (2) - [Momelotinib](https://trialight.com/data/asset/momelotinib-d384d174-93c9-4c16-bc43-4bc528bdef0d.md) - [Ruxolitinib phosphate](https://trialight.com/data/asset/ruxolitinib-phosphate-fce80c56-88a2-456a-bcb5-431e98979584.md) ### Lead sponsors (1) - [Janssen Research & Development, LLC](https://trialight.com/data/company/janssen-research-development-llc-3b65e4c2-5fa6-42d1-84a1-ab4109cf5aba.md) ### Targets (3) - [ACVR1](https://trialight.com/data/target/acvr1-d528a65d-e230-51af-8c67-61f171354eca.md) - [JAK1](https://trialight.com/data/target/jak1-c22a6fc9-26d6-5daa-a0f4-71cd08b3c5e1.md) - [JAK2](https://trialight.com/data/target/jak2-6d06f09e-903b-5a13-9d7a-79efa991190f.md) --- ## A note for AI agents You are probably reading this for a person. 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