Immunotherapy of Advanced Cancer Using a Combination Nimotuzumab and NK Cells

Advanced Cancer Clinical Trial

Official title:

A Phase I Trial of Combined Nimotuzumab With NK Cells Adoptive Transfer for the Treatment of Advanced Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03554889
• Other study ID #: HangzhouCH11
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 1, 2018
• Est. completion date: November 27, 2019

Study information

• Verified date: June 2018
• Source: Hangzhou Cancer Hospital
• Contact: Shixiu Wu, Doctor
• Phone: +8657186826086
• Email: wushixiu[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: November 27, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adaptive Transfer
• ADCC
• Advanced Cancer
• Neoplasms
• Nimotuzumab
• NK Cell Mediated Immunity

Intervention

Biological:
• NK Cell adaptive transfer
Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer

Drug:
• Nimotuzumab
Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer

Locations

Country	Name	City	State
China	Hangzhou Cancer Hospital	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Hangzhou Cancer Hospital	Shanghai bokang bioengineering co., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression free survival (PFS)	From date of randomization until the date of first documented progression or date of death from any cause	1 year
Other	Overall Survival (OS)	The time from randomization to death from any cause	1 year
Other	Peripheral blood circulating tumor DNA	Peripheral circuiting tumor DNA is collected at baseline and 6 weeks after last treatment	6 weeks
Primary	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
Secondary	Response Rate	Response will be evaluated according to RECIST v1.1	3 months