칼레티쿨린(CALR) 돌연변이 골수증식성 신생물 치료를 위한 JNJ-88549968에 대한 연구
CALR 변이 골수증식성 신생물에 대한 T세포 방향 전환 이중특이적 항체인 JNJ-88549968의 안전성, 약동학 및 약력학에 대한 최초의 인간 대상 연구
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Study Contact
- 전화번호: 844-434-4210
- 이메일: Participate-In-This-Study1@its.jnj.com
연구 장소
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Aachen, 독일, 52074
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- Universitaetsklinikum der RWTH Aachen
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Berlin, 독일, 12203
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- Charite Campus Benjamin Franklin
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Essen, 독일, 45147
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- Med. Universitatsklinik Essen
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Hanover, 독일, 30625
- 모병
- Medizinische Hochschule Hannover
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Heidelberg, 독일, 69120
- 모병
- Universitaetsklinikum Heidelberg
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Regensburg, 독일, 93053
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- Universitaetsklinikum Regensburg
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Arizona
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Goodyear, Arizona, 미국, 85338
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- City of Hope Phoenix
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California
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Duarte, California, 미국, 91010
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- City of Hope
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Colorado
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Aurora, Colorado, 미국, 80045
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- UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center
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Florida
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Tampa, Florida, 미국, 33612
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- Moffit Cancer center
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Georgia
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Atlanta, Georgia, 미국, 30322
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- Emory University
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Illinois
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Zion, Illinois, 미국, 60099
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- City of Hope Chicago
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Michigan
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Ann Arbor, Michigan, 미국, 48109
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- University of Michigan
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Grand Rapids, Michigan, 미국, 49546
- 모병
- Start Midwest
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New Jersey
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East Brunswick, New Jersey, 미국, 08816
- 모병
- START New Jersey
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New Brunswick, New Jersey, 미국, 08901
- 모병
- Rutgers Cancer Institute of New Jersey
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New York
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New York, New York, 미국, 10065
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- Memorial Sloan Kettering Cancer Center
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The Bronx, New York, 미국, 10467
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- Montefiore Medical Center
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North Carolina
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Charlotte, North Carolina, 미국, 28204
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- Levine Cancer Institute
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
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- University of Pennsylvania
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South Carolina
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Greenville, South Carolina, 미국, 29605
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- Prisma Health
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Tennessee
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Nashville, Tennessee, 미국, 37203
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- Sarah Cannon Cancer Institute
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Texas
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Houston, Texas, 미국, 77030
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- MD Anderson Cancer Center
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Washington
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Seattle, Washington, 미국, 98104
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- Swedish Cancer Institute
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Badalona, 스페인, 08916
- 모병
- Hosp. Univ. Germans Trias I Pujol
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Valencia, 스페인, 46010
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- Hosp. Clinico Univ. de Valencia
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London, 영국, SE1 9RT
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- Guy's and St Thomas' Hospital
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London, 영국, NW1 2PG
- 모병
- University College London Hospitals Nhs Foundation Trust
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Oxford, 영국, OX3 7LE
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- Churchill Hospital
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Haifa, 이스라엘, 3436212
- 모병
- Carmel Medical Center
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Jerusalem, 이스라엘, 9112001
- 모병
- Hadassah University Hospita Ein Kerem
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Ramat Gan, 이스라엘, 5266202
- 모병
- Sheba Medical Center
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Tel Aviv, 이스라엘, 64239
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- Tel Aviv Sourasky Medical Center
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Bologna, 이탈리아, 40138
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- Policlinico Sant'Orsola Malpighi
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Milan, 이탈리아, 21022
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- Policlinico di Milano
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Bunkyō City, 일본, 113 8431
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- Juntendo University Hospital
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Kashiwa, 일본, 277 8577
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- National Cancer Center Hospital East
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Beijing, 중국, 100032
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- Peking Union Medical College Hospital
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Hangzhou, 중국, 310002
- 모병
- The First Affiliated Hospital Zhejiang University School of Medicine
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Tianjin, 중국, 301617
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- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
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Alberta
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Calgary, Alberta, 캐나다, T2N 4N1
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- Arthur J E Child Comprehensive Cancer Centre
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Ontario
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Toronto, Ontario, 캐나다, M5G 1Z5
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- Princess Margaret Cancer Centre University Health Network
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Quebec
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Montreal, Quebec, 캐나다, H3T 1E2
- 완전한
- Jewish General Hospital
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Paris, 프랑스, 75475
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- Hopital Saint Louis
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Pierre-Bénite, 프랑스, 69495
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- CH LYON SUD - Hematology
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Toulouse, 프랑스, 31059
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- Institut Universitaire du Cancer Toulouse Oncopole
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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:
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Known allergies, hypersensitivity, or intolerance to the excipients of the study treatment
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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
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Prior solid organ transplantation
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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 JNJ-88549968 or
- Evidence of graft versus host disease (GVHD) that requires immunosuppressant therapy
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History of clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Dose Escalation (Part 1), Dose Expansion (Part 2) and Part 1b (US only), Part 2b (US only)
In dose escalation (Part 1), participants will receive JNJ-88549968. For myelofibrosis (MF) participants only, the study will explore a Phase 1b cohort in which the janus kinase (JAK) inhibitor ruxolitinib or momelotinib is started in combination with JNJ-88549968. The dose will be escalated sequentially to determine the recommended phase 2 dose (RP2D) and optimal dosing schedule (s) based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens. Additional Cohorts may be added to assess different formulation or delivery methods. In dose expansion (Part 2, Part 2b [US only]), participants will receive JNJ-88549968 at the RP2D regimen(s) determined in dose escalation (Part 1, Part 1b [US only]). |
JNJ-88549968 will be administered. For US sites: Ruxolitinib will be administered for participants with MF only. For US sites: Momelotinib will be administered for participants with MF only. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Part 1, Part 1b (US Only): Number of Participants With Dose Limiting Toxicity (DLT)
기간: Approximately up to 35 days after first dose of study treatment
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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. |
Approximately up to 35 days after first dose of study treatment
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Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs)
기간: Up to 2 years
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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. |
Up to 2 years
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Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs) by Severity
기간: Up to 2 years
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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. |
Up to 2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Part 1, 2, Part 1b (US Only), Part 2b (US Only): Serum Concentration of JNJ-88549968
기간: Up to 2 years
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Serum samples will be analyzed to determine concentrations of JNJ-88549968. |
Up to 2 years
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Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants With Presence of Anti-Drug Antibodies to JNJ-88549968
기간: Up to 2 years
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Number of participants with presence of anti-drug antibodies to JNJ-88549968 will be reported. |
Up to 2 years
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Part 1, 2, Part 1b (US Only), Part 2b (US Only): Overall Response Rate
기간: Up to 2 years
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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. |
Up to 2 years
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Part 1, 2, Part 1b (US Only), Part 2b (US Only): Complete Response (CR) Rate
기간: Up to 2 years
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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. |
Up to 2 years
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Part 1, 2, Part 1b (US Only), Part 2b (US Only): Time to Response (TTR)
기간: Up to 2 years
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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. |
Up to 2 years
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Part 1, 2, Part 1b (US Only), Part 2b (US Only): Duration of Response (DOR)
기간: Up to 2 years
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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. |
Up to 2 years
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Part 2, Part 2b (US Only): Change From Baseline in Myeloproliferative Neoplasm (MPN) Symptom Burden
기간: Baseline up to 2 years
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Change from baseline in MPN symptom burden assessed using patient reported outcome (PRO) questionnaire will be reported in this outcome measure. |
Baseline up to 2 years
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 88549968MPN1001
- 2023-505584-36-00 (레지스트리 식별자: EUCT number)
- 2023 (미국 NIH 보조금/계약)
- 88549968MPN1001 (기타 식별자: Janssen Research & Development, LLC)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .