Clinical Study on Anti-tumor Effect Induced by Activated Primary Natural Killer（NK）Cells
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|ClinicalTrials.gov Identifier: NCT03634501|
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : January 11, 2019
This study will analyze and evaluate the following items:
- The safety of natural killer（NK） cells for treatment of subjects with solid tumors. Forty patients will be enrolled for each of the five cancers (in total 200 patients will be enrolled).
- The effectiveness of natural killer（NK）cell therapy alone or with chemotherapy or targeted drugs.
Subjects from 18 to 75 years of age who are diagnosed with a solid tumor including pancreatic cancer, lung cancer, breast cancer, ovarian cancer and colon cancer, and for whom standard treatments are not effective, may be eligible for this study. Participants undergo the following procedures:
Peripheral blood will be collected from a vein of arm. Peripheral blood mononuclear cells（PBMC） will be isolated and purified for NK manufacturing. After 14~21 days cultivation, activated NK will be harvested and formulated for clinical administration.
Subjects will receive NK cell treatment by intravenous infusion. The frequency is once every 3 or 4 weeks for the first 3 months. Participants who respond well after 3 months may be eligible to continue NK cell therapy; and those not may receive NK therapy combined with chemotherapy and/or targeted drugs, or chemotherapy/targeted drugs alone.
Evaluations during therapy including:
- Clinical assessment, and history of medications;
- Blood draws for routine and research tests, including but not limited to: lymphocyte population and circulating tumor cell analysis in peripheral blood;
- CT scan, bone scan and positron emission tomography（PET ）scan, if indicated, for disease evaluation;
- Pharmacokinetics study after NK infusion. For this test, the number of NK cells in the blood is measured over time at indicated time-points.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Breast Cancer Colon Cancer Pancreatic Cancer Ovarian Cancer||Biological: Activated NK||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study on Anti-tumor Effect Induced by Activated Primary Natural Killer（NK）Cells|
|Actual Study Start Date :||October 26, 2018|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2022|
Experimental: NK cells
Activated NK from peripheral blood and/or umbilical cord blood（UCB）
Biological: Activated NK
- Incidence of toxicity induced by NK infusion [ Time Frame: 6 months ]The incidence of toxicity within each infusion within 6 months after NK administration
- Objective-response rate (ORR) [ Time Frame: 6 months after 6 infusions of NK administration ]Objective-response rate (ORR): defined as the proportion of patients who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at any time on study.
- Persistence of NK [ Time Frame: Day 0, Day 7, Day30, Day 60, Day 90, Day 180 ]Duration of NK persistence: defined as duration from Day 1 to the time when the NK level goes back to stable level
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634501
|Contact: Zhiguo Chen, PhDfirstname.lastname@example.org|
|Contact: Yu Zhao, PhD||86-10-83198274|
|Beijing, Beijing, China, 100053|
|Contact: Zhiguo Chen|
|Sub-Investigator: Yu Zhao, PhD|
|Sub-Investigator: Fei Li, MD|
|Sub-Investigator: Hua Kang, MD|
|Sub-Investigator: Shijun Wang, MD|
|Sub-Investigator: Yi Zhang, MD|
|Study Director:||Zhiguo Chen, PhD||Xuanwu Hospital, Beijing|