Anti-Inflammatory Agents

All Drugs and Chemicals

Antineoplastic Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Nimotuzumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

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.

Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer

NK Cell adaptive transfer

Shixiu Wu, Doctor

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.

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

From date of randomization until the date of first documented progression or date of death from any cause

The time from randomization to death from any cause

Peripheral circuiting tumor DNA is collected at baseline and 6 weeks after last treatment

Number of Patients with Clinical or Biological Treatment-related Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of a Combination of Nimotuzumab and NK Cell as assessed by CTCAE v4.0

Response will be evaluated according to RECIST v1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Immunotherapy of Advanced Cancer Using a Combination Nimotuzumab and NK Cells	NCT03554889	Advanced Cancer ADCC NK Cell Mediate... Nimotuzumab Adaptive Transf...	NK Cell adaptiv... Nimotuzumab	18 Years - 75 Years	Hangzhou Cancer Hospital
Immunotherapy of Advanced Cancer Using a Combination Nimotuzumab and NK Cells	NCT03554889	Advanced Cancer ADCC NK Cell Mediate... Nimotuzumab Adaptive Transf...	NK Cell adaptiv... Nimotuzumab	18 Years - 75 Years	Hangzhou Cancer Hospital

Spots Global Cancer Trial Database for nk cell adaptive transfer