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| Name | Class |
|---|---|
| Shanghai bokang bioengineering co., LTD | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NK Cell adaptive transfer | Biological | Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 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 | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Response will be evaluated according to RECIST v1.1 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause | 1 year |
| Overall Survival (OS) | The time from randomization to death from any cause |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shixiu Wu, Doctor | Contact | +8657186826086 | wushixiu@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shixiu Wu, Doctor | Hangzhou Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou Cancer Hospital | Hangzhou | Zhejiang | 310002 | China |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
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| Nimotuzumab | Drug | Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer |
|
| 1 year |
| Peripheral blood circulating tumor DNA | Peripheral circuiting tumor DNA is collected at baseline and 6 weeks after last treatment | 6 weeks |