Genetically Modified T Cells Against Ovarian Cancer
Innovative Treatment of Ovarian Cancer Based on Immunogene-modified T Cells (IgT)
調査の概要
詳細な説明
Ovarian cancer (OC) is a cancer that forms in or on an ovary. The majority of OC arises from the epithelium (outer lining) of the ovary. In 2015 OC was found in 1.2 million women and resulted in 161,100 deaths worldwide. Among women it is the seventh-most common cancer and the eighth-most common cause of death from cancer. Treatment for OC consists of surgery, chemotherapy, radiotherapy and sometimes, novel immunotherapies. The best treatment options depend on many factors, including the type of OC, its stage and grade, as well as the general health of the patient.
Adoptive immunotherapy with cytotoxic T lymphocytes reactive with specific antigens has proven to be effective. Novel chimeric antigen receptor gene modified T cell (CART) based immunotherapy has demonstrated great successes in B cell malignancies. Here, the study aim is to evaluate the safety and efficacy of genetically engineered OC-specific and immune modulatory T cells in patients. The primary study objectives are to evaluate the safety of the investigational product, autologous OC-IgT cells, to subjects by IV and intratumoral injection. The secondary study objectives are (1) to evaluate the success rate of generating autologous OC-IgT cells in vitro, and (2) to determine the anti-OC efficacy of the OC-IgT cells.
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Guangdong
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Shenzhen、Guangdong、中国、518000
- 募集
- Shenzhen Geno-Immune Medical Institute
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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:
- Written, informed consent obtained prior to any study-specific procedures.
- Female patients ≥ 20 years.
- Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2.
- Life expectancy ≥ 3 months.
- Able to comply with the protocol.
Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV.
- Complete remission after salvage treatment for first recurrence.
- Not pregnant, and on appropriate birth control if of childbearing potential.
Adequate bone marrow reserve with ·absolute neutrophil count (ANC) ≥ 1000/mm3.
·Platelets ≥100,000/mm3.
Adequate renal and hepatic function with ·Serum creatinine ≤ 2 x upper limit of normal (ULN). ·Serum bilirubin ≤ 2 x ULN.
- aspartate aminotransferase (AST)/ALT ≤ 2 x ULN.
- Alkaline phosphatase ≤ 5 x ULN.
- Serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.
Exclusion Criteria:
1.Patients with:
- Non-epithelial ovarian cancer.
- Ovarian tumors with low malignant potential (i.e. borderline tumors).
- Synchronous primary endometrial carcinoma and ovarian cancer. 2.Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
Previous experience of gene-engineered T cell therapy 4.Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
5.Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).
6.Pregnant or lactating females. 7.Inadequate bone marrow function:
·Absolute neutrophil count < 1.0 x 109/L.
- Platelet count < 100 x 109/L.
- Hb < 9 g/dL. 8. Inadequate liver and renal function:
- Serum (total) bilirubin > 1.5 x ULN.
- AST & ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases).
- Alkaline phosphatase > 2.5 x ULN (or > 5 x ULN in case of liver metastases or > 10 x ULN in case of bone metastases).
- Serum creatinine >2.0 mg/dl (> 177 μmol/L).
Urine dipstick for protein uria should be < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr.
9. Serious active infection requiring i.v. antibiotics at during screening. 10. Subject infected with HIV (HIV antibody positive), Treponema pallidum antibody positive or TB culture positive.
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:なし
- 介入モデル:単一グループの割り当て
- 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 |
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実験的:Single arm
OC-IgT cells to treat ovarian cancer.
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Autologous human OC-IgT cells.
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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 |
---|---|---|
percentage of adverse effects after OC-IgT cells injection
時間枠:up to one month
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To assess the safety of autologous OC-IgT cells in vivo.
The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.
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up to one month
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Rate of successful OC-IgT generation
時間枠:up to one month
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The percentage of successful OC-IgT generation, which are derived from subjects and pass the safety test after standard culture procedures, viable for at least one prepatation, will be evaluated.
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up to one month
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Ability of OC-IgT cells to induce anti-ovarian cancer reaction
時間枠:after 1 month from OC-IgT cells infusion until 12 months after infusion
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measurement of CA125 concentration in blood sample
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after 1 month from OC-IgT cells infusion until 12 months after infusion
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Ability of OC-IgT cells for anti-ovarian cancer reaction
時間枠:after 1 month from OC-IgT cell infusion until 24 months after infusion
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Objective response (complete response (CR) + partial response (PR)) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
CR is disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
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after 1 month from OC-IgT cell infusion until 24 months after infusion
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
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。
卵巣がんの臨床試験
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
OC-IgT cellsの臨床試験
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ViGenCell Inc.まだ募集していません
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University of California, Los AngelesVirtually Better, Inc.完了
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Lumbini Medical College完了閉塞を伴う胆嚢炎を伴う総胆管結石症 | 急性および慢性胆嚢炎を伴う総胆管結石症 | 急性および慢性胆嚢炎を伴う胆石症
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Ocellaris Pharma, Inc.募集肉腫 | 新生物 | 腎細胞がん | 子宮頸癌 | 癌 | 肝細胞癌 | 胃癌 | 卵巣がん | 非小細胞肺がん | 転移性がん | 頭頸部の扁平上皮がん | 膀胱がん | トリプルネガティブ乳がん | 尿路上皮がん | メルケル細胞がん | 扁平上皮癌 | 局所進行性悪性新生物 | 局所進行固形腫瘍 | 尿路上皮新生物カナダ