Genetically Modified T Cells Against Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03184753|
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Biological: OC-IgT cells||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Innovative Treatment of Ovarian Cancer Based on Immunogene-modified T Cells (IgT)|
|Actual Study Start Date :||May 15, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Single arm
OC-IgT cells to treat ovarian cancer.
Biological: OC-IgT cells
Autologous human OC-IgT cells.
- percentage of adverse effects after OC-IgT cells injection [ Time Frame: up to one month ]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.
- Rate of successful OC-IgT generation [ Time Frame: up to one month ]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.
- Ability of OC-IgT cells to induce anti-ovarian cancer reaction [ Time Frame: after 1 month from OC-IgT cells infusion until 12 months after infusion ]measurement of CA125 concentration in blood sample
- Ability of OC-IgT cells for anti-ovarian cancer reaction [ Time Frame: after 1 month from OC-IgT cell infusion until 24 months after infusion ]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.
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): NCT03184753
|Contact: Lung-Ji Chang, PhDfirstname.lastname@example.org|
|Shenzhen Geno-immune Medical Institute||Recruiting|
|Shenzhen, Guangdong, China, 518000|
|Contact: Lung-Ji Chang, PhD 86-075586725195 email@example.com|
|Principal Investigator:||Lung-Ji Chang, PhD||Shenzhen Geno-Immune Medical Institute|