Immunotherapy of Advanced Cancer Using a Combination Nimotuzumab and NK Cells
NCT ID: NCT03554889
Last Updated: 2018-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
21 participants
INTERVENTIONAL
2018-08-01
2019-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental Group
Peripheral blood lymphocytes will be collected. The NK cell will be selected and expanded ex vivo, then adaptive transfer back into patients. A total of 5.0 x 10\^8/L NK cells will be infused in one cycle.To avoid allergic reactions, 50 mg hydrocortisone was intramuscularly injected into patient 30 min before cells infusion every time. Best supportive care was also provided for patients. Nimotuzumab will be used 24 hours before infusion. Patients continued receiving treatment unless they had unacceptable adverse effects, or progressive disease confirmed by CT and PET-CT or they withdrew consent.
NK Cell adaptive transfer
Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer
Nimotuzumab
Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer
Interventions
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NK Cell adaptive transfer
Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer
Nimotuzumab
Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer
Eligibility Criteria
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Inclusion Criteria
2. Measurable disease
3. Progressed after all standard treatment
4. ECOG performance status of 0 to 2
5. Expected life span ≥ 3 months
6. Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy
7. Major organs function normally
8. Women at pregnant ages should be under contraception
9. Willing and able to provide informed consent
Exclusion Criteria
2. Poor vasculature
3. Disease to the central nervous system
4. Blood-borne infectious disease, eg. hepatitis B
5. History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
6. With other immune diseases, or chronic use of immunosuppressants or steroids
7. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
8. Breastfeeding
9. Decision of unsuitableness by principal investigator or physician-in-charge
18 Years
75 Years
ALL
No
Sponsors
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Shanghai bokang bioengineering co., LTD
UNKNOWN
Hangzhou Cancer Hospital
OTHER
Responsible Party
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Shixiu Wu
President of Hangzhou Cancer Hospital
Principal Investigators
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Shixiu Wu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hangzhou Cancer Hospital
Locations
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Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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HangzhouCH11
Identifier Type: -
Identifier Source: org_study_id
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