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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
Sponsor:
Information provided by (Responsible Party):
Zhiguo Chen, Xuanwu Hospital, Beijing

Brief Summary:

This study will analyze and evaluate the following items:

  1. 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).
  2. 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:

  1. Clinical assessment, and history of medications;
  2. Blood draws for routine and research tests, including but not limited to: lymphocyte population and circulating tumor cell analysis in peripheral blood;
  3. CT scan, bone scan and positron emission tomography(PET )scan, if indicated, for disease evaluation;
  4. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: NK cells
Activated NK from peripheral blood and/or umbilical cord blood(UCB)
Biological: Activated NK
Cell suspension




Primary Outcome Measures :
  1. Incidence of toxicity induced by NK infusion [ Time Frame: 6 months ]
    The incidence of toxicity within each infusion within 6 months after NK administration


Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age from 18 to 75 years (including boundary values);
  2. Diagnosed with histologically and cellularly confirmed cancer of lung, breast, pancreas, ovary, or colon;
  3. At least 8 weeks since any prior systemic therapy to treat the underlying malignancy (standard or investigational);
  4. Life expectancy > 6 months, and performance status(KPS)> 60 points;
  5. Organ functions meet the following criteria:

    1. Blood bilirubin < 2mg/dL,
    2. Aspartate transaminase(AST)<100 IU/L,
    3. Alanine transaminase(ALT) <100 IU/L,
    4. Creatinine <1.5 mg/dL,
    5. Urea nitrogen ≤ 25 mg/dL,
    6. Hemoglobin ≥ 9.0 g/dL,
    7. White blood cell count>3.5×109/L,
    8. Neutrophil count >1.5x109/L,
    9. Platelet count > 80 × 109 /L,
    10. Hematocrit >0.20,
  6. No severe infections.

Exclusion Criteria:

  1. Subjects who take combined systemic steroids within 2 weeks prior to treatment (except inhaled steroids);
  2. Patients who take chemotherapy within 1 month prior to treatment;
  3. Subjects receiving drugs that stimulate the production of bone marrow hematopoietic cells within two weeks prior to treatment;
  4. Patients with T lymphoma and NK cell lymphoma;
  5. Patients with autoimmune diseases, including but not limited to lupus erythematosus, rheumatoid arthritis, etc.;
  6. Seriously uncontrollable infected patients;
  7. Patients who are allergic to the biological agents in this treatment;
  8. Patients with organ transplantation or organ failure;
  9. Subjects with severe cardiovascular disease and severe renal failure;
  10. Patients who are undergoing treatment of immunosuppressive drugs or long-term administration of immunosuppressive drugs after organ transplantation;
  11. Patients with active infection or fever;
  12. Subjects with severe cardiovascular and cerebrovascular diseases, diabetes and renal dysfunction;
  13. Subjects with pregnancy or during the lactating period.

Information from the National Library of Medicine

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): NCT03634501


Contacts
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Contact: Zhiguo Chen, PhD 86-10-83198889 chenzhiguo@gmail.com
Contact: Yu Zhao, PhD 86-10-83198274

Locations
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China, Beijing
Xuanwu Hospital Recruiting
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         
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Study Director: Zhiguo Chen, PhD Xuanwu Hospital, Beijing

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Responsible Party: Zhiguo Chen, Professor, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03634501     History of Changes
Other Study ID Numbers: XuanWuH-NK
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases