비호지킨림프종(NHL) 및 만성림프구성백혈병(CLL)에서 T세포전향항체 JNJ-80948543 연구
NHL 및 CLL 환자를 대상으로 한 T 세포 방향 전환 항체 JNJ-80948543의 1상 인체 최초 연구
The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]), optimal dosing schedule(s) and route(s) of administration of JNJ-80948543 in Part A (Dose Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort Expansion).
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
-
-
-
Copenhagen, 덴마크, 2100
- Rigshospitalet
-
Odense, 덴마크, 5000
- Odense University Hospital
-
-
-
-
California
-
Duarte, California, 미국, 91010
- City of Hope
-
-
New York
-
New York, New York, 미국, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, 미국, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Tennessee
-
Nashville, Tennessee, 미국, 37203
- Sarah Cannon Research Institute
-
-
Texas
-
Houston, Texas, 미국, 77030
- The University of Texas MD Anderson Cancer Center
-
San Antonio, Texas, 미국, 78229
- Texas Transplant Institute
-
-
Washington
-
Seattle, Washington, 미국, 98109
- Seattle Cancer Care Alliance
-
-
-
-
-
Haifa, 이스라엘, 34362
- Carmel Medical Center
-
Jerusalem, 이스라엘, 9112001
- Hadassah Medical Center
-
Tel Aviv, 이스라엘, 64239
- Tel Aviv Sourasky Medical Center
-
-
-
-
-
Kashiwa, 일본, 277 8577
- National Cancer Center Hospital East
-
Nagoya, 일본, 464 8681
- Aichi Cancer Center
-
Tokyo, 일본, 135 8550
- The Cancer Institute Hospital of JFCR
-
-
-
-
-
Chongqing, 중국, 400044
- Chongqing University Cancer Hospital
-
Guangzhou, 중국, 510060
- Sun Yat Sen University Cancer Center
-
Tianjin, 중국, 300060
- Tianjin cancer hospital
-
Wuhan, 중국, 430030
- Union Hospital Tongji Medical College of Huazhong University of Science and Technology
-
-
-
-
-
Gdansk, 폴란드, 80 214
- Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
-
Skorzewo, 폴란드, 60-185
- Aidport Sp z o o
-
-
-
-
-
Lille, 프랑스, 59037
- CHRU de Lille Hopital Claude Huriez
-
Paris, 프랑스, 75005
- Institut Curie
-
Strasbourg, 프랑스, 67033
- Institut de Cancerologie Strasbourg Europe ICANS
-
Toulouse, 프랑스, 31059
- Institut Universitaire du cancer de Toulouse-Oncopole
-
-
-
-
-
Macquarie University, 호주, 2109
- Macquarie University Hospital
-
Melbourne, 호주, 3004
- The Alfred Hospital
-
Nedlands, 호주, 6009
- Linear Clinical Research Ltd
-
Randwick, 호주, 2031
- Scientia Clinical Research
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologic documentation of disease: B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) requiring therapy.
All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment.
B-cell NHL as defined per the 2016 world health organization (WHO) classification. In addition, the following disease-specific criteria outlined below must be met:
If diffuse large B-cell lymphoma (DLBCL) or other high-Grade B-cell lymphoma: Received, or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent or deemed not eligible or fit for an alternative 2nd line therapy. Participants may be eligible if relapsing after chimeric antigen receptors (CAR-T) cell treatment or while waiting for a CAR-T cell treatment.
If transformed lymphoma from low Grade B-cell malignancies: Received or not a candidate for an approved first-line regimen for DLBCL and received or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent.
If follicular lymphoma (FL) (all grades): Previously treated with a minimum of 2 prior lines of systemic therapy, with at least one prior line containing an anti-CD20 antibody.
If mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) (including nodal, extranodal/MALT, and splenic MZL subtypes): Previously treated with at least 2 lines of systemic therapy. H.pylori-positive gastric MALT lymphoma must have failed prior H. pylori eradication therapy as one of their prior lines .
Waldenstrom macroglobulinemia (WM): Previously treated with at least 1 line of systemic therapy.
small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL/SLL): Relapsed or refractory with at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor (BTK) inhibitor or a BCL2 inhibitor, if eligible. In addition for part B Participants must have measurable disease as defined by the appropriate disease response criteria
- Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1
- Cardiac parameters within the following range: corrected QT interval (QTc intervals corrected using Fridericia's formula [QTcF]) less than or equal to (<=) 480 milliseconds based on the average of triplicate assessments performed no more than 5 (plus minus [+-] 3) minutes apart
- A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta- human chorionic gonadotropin) at screening and must agree to further serum or urine pregnancy tests prior to the first dose, during the study and until 3 months after the last dose of study treatment
- A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study treatment
Exclusion Criteria:
- Known active central nervous system (CNS) involvement; Lymphoma with CNS involvement may be allowed in pharmacokinetic/ pharmacodynamic (PK/PD) and expansion cohorts if approved by the study evaluation team (SET)
- Prior solid-organ transplantation
- Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug
- Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade <= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2)
- Clinically significant pulmonary compromise, particularly the need for supplemental oxygen use to maintain adequate oxygenation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Part A: Dose Escalation
Participants will receive JNJ-80948543 either by subcutaneous (SC) or intravenous (IV) administration to determine the putative recommended Phase 2 dose (RP2D) dosing schedule(s) and route(s) of administration based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens. |
JNJ-80948543 will be administered as SC or IV injection. |
|
실험적: Part B: Cohort Expansion
Participants will receive JNJ-80948543 by SC or IV administration. |
JNJ-80948543 will be administered as SC or IV injection. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants with Dose-limiting Toxicity (DLT)
기간: Up to 4 Years 3 months
|
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. |
Up to 4 Years 3 months
|
|
Number of Participants with Adverse Events (AEs)
기간: Up to 4 Years 3 months
|
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. |
Up to 4 Years 3 months
|
|
Number of Participants with AE by Severity
기간: Up to 4 Years 3 months
|
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 4 (Life-threatening). 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 immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded as per American Society for Transplantation and Cellular Therapy (ASTCT). |
Up to 4 Years 3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Serum Concentration of JNJ-80948543
기간: Up to 4 Years 3 months
|
Serum samples will be analyzed to determine concentrations of JNJ-80948543 using a validated, specific, and sensitive method. |
Up to 4 Years 3 months
|
|
Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543
기간: Up to 4 Years 3 months
|
Number of participants with presence of anti-drug antibodies of JNJ-80948543 will be assessed. |
Up to 4 Years 3 months
|
|
Overall Response Rate (ORR)
기간: Up to 4 Years 3 months
|
ORR is defined as the percentage of participants who have a best response of partial response (PR) or better. |
Up to 4 Years 3 months
|
|
Complete Response (CR) Rate
기간: Up to 4 Years 3 months
|
CR rate is defined as the percentage of participants who achieve a best response of CR. |
Up to 4 Years 3 months
|
|
Rate of VGPR or Better for Participants with Waldenstrom Macroglobulinemia (WM)
기간: Up to 4 Years 3 months
|
The response criteria planned to be used for participants with WM includes a category of VGPR, which is clinically understood to be better than PR but not as good as CR. For participants with WM, this rate is defined as the proportion of participants who achieve a best response of VGPR or better. |
Up to 4 Years 3 months
|
|
Time to Response (TTR)
기간: Up to 4 Years 3 months
|
TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR. |
Up to 4 Years 3 months
|
|
Duration of Response (DOR)
기간: Up to 4 Years 3 months
|
DOR is defined for participants who achieved a response of PR or better as the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death. |
Up to 4 Years 3 months
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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
- CR109174
- 2022-000685-18 (EudraCT 번호)
- 80948543LYM1001 (기타 식별자: Janssen Research & Development, LLC)
- 2023-504187-42-00 (레지스트리 식별자: EUCT number)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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
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. .