Trial | NCT03554889  Report issue

Title

Immunotherapy of Advanced Cancer Using a Combination Nimotuzumab and NK Cells
A Phase I Trial of Combined Nimotuzumab With NK Cells Adoptive Transfer for the Treatment of Advanced Cancer

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    21
NK cells can persist and expand in vivo following adoptive transfer and may have a role in the treatment of late stage malignancies. NK also express an activating Fc receptor that mediates antibody-dependent cellular cytotoxicity (ADCC) and production of immune modulatory cytokines in response to antibody-coated targets. Nimotuzumab, an monoclonal antibody against EGFR (epidermal growth factor receptor), may enhance the ADCC effect of NK cell. This study will evaluate the safety of combination of nimotuzumab and NK Cell in treating advanced cancer patients. Blood samples will also be collected for research purposes.
This is a phase I clinical study of expanded NK cells from autologous origin. The NK cell will be selected and expanded ex vivo and infused back into patients. Nimotuzumab will be used 24 hours before infusion. 21 advanced cancer patients are planned to receive two cycles of NK cells and Nimotuzumab treatment. Biomarkers and immunological markers are collected and analyzed as well.
Study Started
Aug 01
2018
Anticipated
Primary Completion
Mar 30
2019
Anticipated
Study Completion
Nov 27
2019
Anticipated
Last Update
Jun 13
2018

Biological NK Cell adaptive transfer

Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer

Drug Nimotuzumab

Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer

Experimental Group Experimental

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.

Criteria 

Inclusion Criteria:

Histologically confirmed recurrent or metastatic cancer
Measurable disease
Progressed after all standard treatment
ECOG performance status of 0 to 2
Expected life span ≥ 3 months
Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy
Major organs function normally
Women at pregnant ages should be under contraception
Willing and able to provide informed consent

Exclusion Criteria:

Other malignancy within 5 years prior to entry into the study, expect for treated non melanoma skin cancer and cervical carcinoma in situ
Poor vasculature
Disease to the central nervous system
Blood-borne infectious disease, eg. hepatitis B
History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
With other immune diseases, or chronic use of immunosuppressants or steroids
Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
Breastfeeding
Decision of unsuitableness by principal investigator or physician-in-charge
No Results Posted