Adaptive Transfer, ADCC, Advanced Cancer, Nimotuzumab, NK Cell Mediated Immunity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALNK Cell adaptive transfer
Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer
DRUGNimotuzumab
Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer
Sponsors
Shanghai bokang bioengineering co., LTD
Hangzhou Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed recurrent or metastatic cancer 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
1. Other malignancy within 5 years prior to entry into the study, expect for treated non melanoma skin cancer and cervical carcinoma in situ 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 6 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 3 months | Response will be evaluated according to RECIST v1.1 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 1 year | From date of randomization until the date of first documented progression or date of death from any cause |
| Overall Survival (OS) | 1 year | The time from randomization to death from any cause |
| Peripheral blood circulating tumor DNA | 6 weeks | Peripheral circuiting tumor DNA is collected at baseline and 6 weeks after last treatment |
Countries
China
Contacts
Primary ContactShixiu Wu, Doctor
Outcome results
None listed