Engineered Immune Effectors Against Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT03362619|
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Biological: CC-EIEs||Phase 1 Phase 2|
Cervical cancer (CC) is a cancer arising from the cervix. Human papillomavirus (HPV) infection causes more than 90% of the cases. Other risk factors include smoking, a weak immune system, birth control pills, starting sex at a young age, and having many sexual partners, but these are less important. Worldwide, CC is both the fourth-most common cause of cancer and the fourth-most common cause of death from cancer in women. The treatment of CC consists of surgical intervention, radiation, chemotherapy and immunotherapy.
Adoptive immunotherapy with cytotoxic T lymphocytes reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of CC-specific engineered immune effectors including 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:||Innovative Treatment of Cervical Cancer Using Engineered Antigen-specific Immune Effectors (EIEs)|
|Actual Study Start Date :||November 15, 2017|
|Actual Primary Completion Date :||January 31, 2019|
|Estimated Study Completion Date :||December 2020|
Autologous cervical cancer specific engineered immune effectors (EIEs)
2 to 4 infusions, once a week, for 1x10^5~1x10^7 CTLs/kg via IV, abdominal cavity or intratumoral injection each time
- Safety of CC-EIEs 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 CC-EIEs in vitro [ Time Frame: 4 weeks ]The specificity of CC-EIEs 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): NCT03362619
|Contact: Lung-Ji Chang, PhDemail@example.com|
|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 firstname.lastname@example.org|
|Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center||Recruiting|
|Kunming, Yunnan, China, 650000|
|Contact: Xun Lai, MD 13577096609 email@example.com|
|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|