Engineered Immune Effectors Against Ovarian Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03362606|
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Biological: OC-CTLs||Phase 1 Phase 2|
Ovarian cancer is a cancer that forms in or on an ovary. The majority of ovarian cancers arise from the epithelium (outer lining) of the ovary. In 2015 it was reported 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 ovarian cancer consists of surgery, chemotherapy, immunotherapy and sometimes, radiotherapy. The kind of treatment depends on many factors, including the type of ovarian cancer, its stage and grade, as well as the general health of the patient.
Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of ovarian cancer specific cytotoxic T lymphocytes in patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intervention of Ovarian Cancer Based on Engineered Immune Effectors (EIEs)|
|Actual Study Start Date :||November 15, 2017|
|Actual Primary Completion Date :||January 31, 2019|
|Estimated Study Completion Date :||December 2020|
Autologous ovarian cancer specific cytotoxic lymphocytes
2 to 4 infusions, once a week, for 1x10^5~4x10^6 CTLs/kg via IV, abdominal cavity or tumor injection each time
- Safety of OC-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events [ Time Frame: 6 months ]Physiological parameter (measuring cytokine response, fever, symptoms)
- Functional analyses of OC-CTLs in vitro [ Time Frame: 4 weeks ]The specificity of OC-CTLs in vitro will be analysed by enzyme-linked immunospot assay (ELISPOT).
- Anti-tumor effects [ Time Frame: 1 year ]Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362606
|Contact: Lung-Ji Chang, PhDfirstname.lastname@example.org|
|Jinshazhou Hospital of Guangzhou University of Chinese Medicine||Recruiting|
|Guangzhou, Guangdong, China, 510415|
|Contact: Qichun Cai, MD 86-13802830754|
|Shenzhen Geno-immune Medical Institute||Recruiting|
|Shenzhen, Guangdong, China, 518000|
|Contact: Lung-Ji Chang, PhD 86-075586725195 email@example.com|
|Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center||Recruiting|
|Kunming, Yunnan, China, 650000|
|Contact: Xun Lai, MD 13577096609 firstname.lastname@example.org|
|Principal Investigator:||Lung-Ji Chang, PhD||Shenzhen Geno-Immune Medical Institute|
|Study Director:||Qichun Cai, MD||Jinshazhou Hospital of Guangzhou University of Chinese Medicine|
|Study Director:||Xun Lai, MD||Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center|