B細胞非ホジキンリンパ系（NHL）がんの参加者におけるJNJ-87801493とT細胞エンゲイジャーの併用の研究
再発/難治性B細胞非ホジキンリンパ系悪性腫瘍（NHL）の参加者を対象としたCD3 T細胞関与因子とJNJ-87801493の併用による第1相ファースト・イン・ヒト試験
The purpose of this study is to characterize safety and to determine the recommended phase 2 regimen (RP2R) for JNJ-87801493 in combination with T-cell engagers (TCEs) [Part A: Dose Escalation] and to further assess the safety of JNJ-87801493 at the RP2R in combination with TCEs [Part B: Dose Expansion].
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
-
Jerusalem、イスラエル、9112001
- Hadassah Medical Center
-
Tel Aviv、イスラエル、6423906
- Sourasky (Ichilov) Medical Center
-
-
-
-
-
Heidelberg、オーストラリア、3084
- Austin Hospital
-
Melbourne、オーストラリア、3004
- The Alfred Hospital
-
Nedlands、オーストラリア、6009
- Linear Clinical Research Ltd
-
Randwick、オーストラリア、2031
- Scientia Clinical Research
-
-
-
-
-
Barcelona、スペイン、08035
- Hosp Univ Vall D Hebron
-
Madrid、スペイン、28040
- Hosp Univ Fund Jimenez Diaz
-
Pamplona、スペイン、31008
- Clinica Univ. de Navarra
-
Salamanca、スペイン、37007
- Hosp Clinico Univ de Salamanca
-
-
-
-
-
Copenhagen、デンマーク、DK-2100
- Rigshospitalet
-
Odense、デンマーク、5000
- Odense University Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Histologic documentation of B-cell NHL. All participants in part 1 must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment. In Part 2, participants with diffuse large B-cell lymphoma (DLBCL) or other high-grade B cell lymphoma and participants with transformed lymphoma from low-grade B cell malignancies who relapsed or failed to respond to only one prior systemic treatment regimen can be included
- Part 1 participants must have evaluable or measurable disease and Part 2 participants must have measurable disease; all as defined by the Lugano criteria for non-Hodgkin lymphoid malignancies (NHL) and the international workshop on Waldenstrom's Macroglobulinemia (IWWM-6) for WM
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Hematologic laboratory parameters must meet the required criterias and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of study drug
- Participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (β)-human chorionic gonadotropin) at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
Exclusion Criteria:
- Known active central nervous system involvement (CNS) or leptomeningeal involvement. CNS involvement may be allowed in specific cohorts as determined by the Study Evaluation Team (SET)
- Prior solid-organ transplantation
- Prior treatment with JNJ-80948543 and/or JNJ-75348780. In addition, history of known allergies, hypersensitivity, or intolerance to either JNJ-80948543, JNJ-75348780, or JNJ-87801493 or its excipients
- Chemotherapy, targeted therapy, or immunotherapy within 2 weeks before the first dose of study treatment. For investigational agents where the half-life is known, there should be a treatment-free window of at least 2 weeks or 5 half-lives. For checkpoint blockade therapy (example, anti-programmed cell death protein-1 [anti-PD-1]), a washout period of up to 6 weeks may be considered
- Malignancy diagnosis other than the disease under study within 1 year prior to 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 the study drugs in the opinion of both the investigator and sponsor's medical monitor
- Autoimmune or inflammatory disease requiring systemic corticosteroids or other immunosuppressive agents within 1 year prior to first dose of study treatment
- Evidence of active viral, bacterial, or uncontrolled systemic fungal infection requiring systemic treatment within 7 days before the first dose of study treatment
- Abnormal cardiac function
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Part 1: Dose escalation
Participants will receive one cycle of TCE monotherapy (step up dosing) with either JNJ-80948543 or JNJ-75348780 followed by initiation of combination therapy with JNJ-87801493 at least one week later. |
JNJ-87801493 will be administered subcutaneously. JNJ-80948543 will be administered subcutaneously. JNJ-75348780 will be administered subcutaneously. |
|
実験的：Part 2:Dose expansion
Participants with specific B-cell NHL histologies will receive recommended phase 2 regimen (RP2R) of JNJ-87801493 with TCE as determined in Part 1. |
JNJ-87801493 will be administered subcutaneously. JNJ-80948543 will be administered subcutaneously. JNJ-75348780 will be administered subcutaneously. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
時間枠：Up to 2 years 7 months
|
Number of participants with DLTs will be reported. The DLTs are drug-related toxicities and are defined as any of the following: fatal toxicity, high grade non-hematologic toxicity, or hematologic toxicity |
Up to 2 years 7 months
|
|
Part 1 and 2: Percentage of Participants with Adverse Events (AEs) by Severity
時間枠：Up to 2 years 7 months
|
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity for AEs will be specified as per: NCI-CTCAE grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and; American Society for Transplantation and Cellular Therapy (ASTCT) guidelines which is Grade 5 (death related to adverse event); Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events [ICANS]). |
Up to 2 years 7 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780
時間枠：Up to 2 years 7 months
|
Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Area Under the Curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
時間枠：Up to 2 years 7 months
|
AUC tau is defined as area under the serum concentration-time curve during a dosing interval (tau).Area under the serum concentration curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Maximum Serum Concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
時間枠：Up to 2 years 7 months
|
Maximum observed serum concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Minimum Serum Concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
時間枠：Up to 2 years 7 months
|
Minimum observed serum concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Area Under the Curve (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
時間枠：Up to 2 years 7 months
|
Area under the curve from time zero to t (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
時間枠：Up to 2 years 7 months
|
Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Time to Reach Cmax (Tmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
時間枠：Up to 2 years 7 months
|
Tmax is the time to reach maximum observed serum concentartion for JNJ-87801493, JNJ-80948543 and JNJ-75348780. |
Up to 2 years 7 months
|
|
Apparent Total Body Clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
時間枠：Up to 2 years 7 months
|
Apparent total body clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Apparent Volume of Distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
時間枠：Up to 2 years 7 months
|
Apparent volume of distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
|
|
Number of Participants with Presence of Anti-JNJ-87801493, Anti-JNJ- 80948543 and Anti-JNJ-75348780 Antibodies
時間枠：Up to 2 years 7 months
|
Number of participants with presence of antibodies binding to JNJ-87801493 or each combination partner (JNJ- 80948543 and JNJ-75348780). |
Up to 2 years 7 months
|
|
Overall Response as Assessed by the Investigator
時間枠：Up to 2 years 7 months
|
Overall response is defined as a best response of partial response (PR) or better. |
Up to 2 years 7 months
|
|
Complete Response (CR) as Assessed by the Investigator
時間枠：Up to 2 years 7 months
|
Complete response (CR) is defined as a best response of CR. |
Up to 2 years 7 months
|
|
Very Good Partial Response (VGPR) or better for Waldenström Macroglobulinemia (WM) Participants as Assessed by the Investigator
時間枠：Up to 2 years 7 months
|
Very good partial response (VGPR) or better is defined as a best response of VGPR or better. |
Up to 2 years 7 months
|
|
Time to Response (TTR) as Assessed by the Investigator
時間枠：Up to 2 years 7 months
|
Time to response (TTR) is defined for participants who achieve a response of PR or better as the time from the first dose of any study drug to the first response of PR or better. |
Up to 2 years 7 months
|
|
Duration of Response (DOR) as Assessed by the Investigator
時間枠：Up to 2 years 7 months
|
Duration of response (DOR) is defined for participants who achieved a response of PR or better as the time from the first efficacy evaluation at which the participant meet all criteria for a response of PR or better to the date of first documented evidence of progressive disease or death. |
Up to 2 years 7 months
|
協力者と研究者
捜査官
- スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 87801493LYM1001
- 87801493LYM1001 (その他の識別子：Janssen Research & Development, LLC)
- 2023-505165-93-00 (レジストリ識別子：EUCT number)
- 2023 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The data sharing policy of Johnson & Johnson Innovative Medicine is available at 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
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。