Overview

Immunotherapy of Advanced Cancer Using a Combination Nimotuzumab and NK Cells

Status:
Unknown status
Trial end date:
2019-11-27
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hangzhou Cancer Hospital
Collaborator:
Shanghai bokang bioengineering co., LTD
Treatments:
Nimotuzumab
Criteria
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