治験レーダーAI | ||
|---|---|---|
治験 NCT07225439（対象：非ホジキンリンパ腫、B細胞非ホジキンリンパ腫、びまん性大細胞型B細胞リンパ腫、高悪性度B細胞リンパ腫、原発性縦隔大細胞型B細胞リンパ腫、濾胞性リンパ腫、慢性リンパ性白血病、小リンパ球性リンパ腫、辺縁帯リンパ腫、マントル細胞リンパ腫）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) 第I相・フェーズ1 15
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07225439 は 治療 の研究で、非ホジキンリンパ腫、B細胞非ホジキンリンパ腫、びまん性大細胞型B細胞リンパ腫、高悪性度B細胞リンパ腫、原発性縦隔大細胞型B細胞リンパ腫、濾胞性リンパ腫、慢性リンパ性白血病、小リンパ球性リンパ腫、辺縁帯リンパ腫、マントル細胞リンパ腫 に関するものです。この 第I相・フェーズ1 介入研究 臨床試験 は現在 募集準備中 で、2025年12月1日 に開始予定です。15 名の参加者 の募集が計画されています。この試験は Paolo Caimi, MD によって主導され、2027年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年11月6日 です。
概要
This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma.
NK cells are an investigational (experimental) tr...
もっと見る詳細説明
More than 80,000 cases of non-Hodgkin lymphoma (NHL) are diagnosed each year in the United States (US), with nearly 20,000 people dying from this group of diseases annually. There are several subgroups of NHL, with the B cell lymphomas being much more common than T-cell lymphomas. B cell lymphomas include multiple different diseases, including some that are more aggressive (like diffuse large B cell lymphoma (DLBCL) ...もっと見る
公式タイトル
Phase I Clinical Trial of Rituximab (Rtx) and Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma
疾患名
非ホジキンリンパ腫B細胞非ホジキンリンパ腫びまん性大細胞型B細胞リンパ腫高悪性度B細胞リンパ腫原発性縦隔大細胞型B細胞リンパ腫濾胞性リンパ腫慢性リンパ性白血病小リンパ球性リンパ腫辺縁帯リンパ腫マントル細胞リンパ腫刊行物
この臨床試験について発表された科学記事と研究論文：- Non-Hodgkin Lymphoma - Cancer Stat Facts [Internet]. [cited 2024 Jul 31]. Available from: https://seer.cancer.gov/statfacts/html/nhl.html
- Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Re...
その他の研究識別子
- CASE1425
NCT番号
開始日
2025-12
最終更新日
2025-11-06
終了予定日
2027-12
目標参加者数
15
試験の種類
介入研究
治験の相・段階
第I相・フェーズ1
状況
募集準備中
キーワード
NK cells
Natural Killer cells
Natural Killer cells
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Rtx + Tafasitamab in combination with allogeneic NK Cells This arm includes dose escalation for allogeneic NK cells. All other therapies are given according to standard of care. The length of the treatment period is 28 days per cycle. Participants will be expected to complete one cycle and may have the option to complete a second cycle unless there is evidence of disease progression at the end of the first cycle. | Allogeneic NK cells Allogeneic NK cells are given intravenously (IV) weekly for 3 weeks on Days 0, 7, 14.
Dose escalation will be conducted using a Bayesian optimal interval (BOIN) design starting at dose level 1 (500 x 106 cells) and proceeding to dose level 2 (1,000 x 106 cells) if criteria are met. リツキシマブ Rtx is dosed at 375mg/m2 and give once (on Day -5 for Cycle 1 and Day 0 for Cycle 2, if applicable). Tafasitamab Tafasitamab is dosed at 12 mg/kg and given intravenously (IV) weekly for 3 weeks on Days 0,7,14). Interleukin-2 Interleukin-2 is dosed at 5 million IU and given weekly for 3 weeks on Days 0,7,14. Fludarabine/cyclophosphamide Fludarabine is dosed at 30 mg/m2/d with dose adjustment for renal function, and cyclophosphamide is dosed at 500 mg/m2/d. These are given on 3 days (Days -5 to -3). |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Dose limiting toxicity (DLT) | Non hematologic AEs will be measured during cycle 1 (first 28 days) and hematologic AEs will be measured during the first 42 days for all dose levels. DLTs are graded for severity by the Common Terminology Criteria for Adverse Events v5.0 (CTCAEv5.0) criteria. | Up to 42 days |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Incidence of adverse events (AEs) | Up to 12 months | |
Timing of adverse events (AEs) | Up to 12 months | |
Severity of adverse events (AEs) | AE severity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 | Up to 12 months |
Complete response (CR) rate | CR is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy and measured according to the 2014 Lugano Response for Malignant Lymphoma criteria. | Day 28 |
Complete response (CR) rate | CR is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy and measured according to the 2014 Lugano Response for Malignant Lymphoma criteria. | Day 100 |
Overall response rate (ORR) | ORR is defined as the rate of participants who had CR and partial response (PR). CR is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy and measured according to the 2014 Lugano Response for Malignant Lymphoma criteria. PR is defined as not meeting criteria for CR but having an improvement in symptom criteria specified by the 2014 Lugano Response for Malignant Lymphoma criteria. | Day 28 |
Overall response rate (ORR) | ORR is defined as the rate of participants who had CR and partial response (PR). CR is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy and measured according to the 2014 Lugano Response for Malignant Lymphoma criteria. PR is defined as not meeting criteria for CR but having an improvement in symptom criteria specified by the 2014 Lugano Response for Malignant Lymphoma criteria. | Day 100 |
Overall survival (OS) | OS is defined as the time from infusion until death from any cause, or until last contact if alive | Up to 12 months |
Event-free survival (EFS) | EFS is defined as the time from infusion until the first occurrence of an event (relapse, progression, or death from any cause), or until last contact if no event occurs. | Up to 12 months |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Age 18 years or older
- Diagnosis of B-cell NHL (indolent and aggressive subtypes) including diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)
- Participants must have measurable disease as defined by Lugano 2014 criteria for NHL or iwCLL 2018 criteria for CLL. For NHL, measurable disease is defined as ≥1 measurable lesion (nodal or extra nodal) ≥1.5 cm in longest diameter by CT or PET/CT. For CLL, iwCLL criteria includes: presence of lymphocytosis (e.g., ALC ≥5 × 10⁹/L), lymphadenopathy ≥1.5 cm, and/or disease-related cytopenias (anemia, thrombocytopenia).
- Relapsed and/or refractory after two or more lines of systemic therapy, including prior CD19 and/or CD20 directed therapies
- For participants who have received a prior CD19 or CD20 directed therapy, the presence of CD19 and/or CD20 expression (by flow cytometry and/or immunohistochemistry) must be demonstrated on a post-treatment relapse biopsy
- ECOG Performance Status </= 2
- Preserved organ function as defined by: Total bilirubin </= 1.5X upper limit of normal; AST/ALT </= 2.5 X upper limit of normal; Calculated creatinine clearance >/= 30mL/min estimated by Cockcroft Gualt formula; cardiac ejection fraction >/= 45% and no more than mild/trace pericardial effusion on a recent echocardiogram; and adequate pulmonary function with oxygen saturation >/= 92% on room air.
- Participants must have the ability to understand and the willingness to sign a written informed consent document
- Second active malignancy (other than non-melanoma skin cancer or carcinoma in situ e.g. cervix, bladder, breast) that would confound interpretation of toxicity assessment or limit survival to prevent evaluation of therapy per discretion of principal investigator. Malignancies treated curatively or with hormonal therapy could be included after discussion with the principal investigator
- Less than 28 days elapsed between prior treatment with investigational agent(s) and study enrollment
- New York Heart Association class III-IV congestive heart failure
- Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration
- Known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness, except well controlled HIV with viral load <200 copies/mL on antiretroviral therapy
- Pregnant or breastfeeding women are excluded from this study because therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants' secondary to treatment of the mother with NK cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study
- Morphologic and/or cytogenetic features consistent with diagnosis of myelodysplastic syndrome on the most recent bone marrow biopsy prior to initiation of therapy
- Serologic status reflecting active hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive participants will be excluded)
- Participants with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease
- Active central nervous system or leptomeningeal involvement by lymphoma. Participants with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurological and other adverse events. Participants with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast enhanced MRI imaging for at least 90 days prior to registration
- History of active autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of systemic immunosuppressive medications other than low dose steroids \[i.e. maximum of 15mg prednisone equivalent\] within the last 6 months
Paolo Caimi, MDインサイト責任者
Paolo Caimi, MD, 治験依頼者・主任研究者, Principal Investigator, Case Comprehensive Cancer Center
試験中央連絡先
連絡先: Paolo Caimi, MD, (216) 445-4635, [email protected]
2 1カ国の場所
Ohio
Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center, Cleveland, Ohio, 44106, United States
Changchun (George) Deng, 連絡先, [email protected]
Changchun (George) Deng, MD, 主任研究者
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute, Cleveland, Ohio, 44195, United States
Paolo Caimi, MD, 連絡先, [email protected]
Paolo Caimi, MD, 主任研究者