Clinical trial NCT03554889: Immunotherapy of Advanced Cancer Using a Combination Nimotuzumab and NK Cells
Official title: A Phase I Trial of Combined Nimotuzumab With NK Cells Adoptive Transfer for the Treatment of Advanced Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Cancer
ADCC
NK Cell Mediated Immunity
Nimotuzumab
Adaptive Transfer
Lead sponsor: Hangzhou Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai bokang bioengineering co., LTD
First posted: 2018-06-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 6 month
Secondary outcomes:
measure: Response Rate
timeFrame: 3 months
Other outcomes:
measure: Progression free survival (PFS)
timeFrame: 1 year
measure: Overall Survival (OS)
timeFrame: 1 year
measure: Peripheral blood circulating tumor DNA
timeFrame: 6 weeks
Locations:
city: Hangzhou
country: China
facility: Hangzhou Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Hangzhou Cancer Hospital
name: Shixiu Wu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: