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Immunotherapy of Advanced Cancer Using a Combination Nimotuzumab and NK Cells

Sponsor
Hangzhou Cancer Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03554889
Collaborator
Shanghai bokang bioengineering co., LTD (Other)
21
Enrollment
1
Location
1
Arm
15.9
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Trial of Combined Nimotuzumab With NK Cells Adoptive Transfer for the Treatment of Advanced Cancer
Anticipated Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Mar 30, 2019
Anticipated Study Completion Date :
Nov 27, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

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.

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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Response Rate [3 months]

    Response will be evaluated according to RECIST v1.1

Other Outcome Measures

  1. Progression free survival (PFS) [1 year]

    From date of randomization until the date of first documented progression or date of death from any cause

  2. Overall Survival (OS) [1 year]

    The time from randomization to death from any cause

  3. Peripheral blood circulating tumor DNA [6 weeks]

    Peripheral circuiting tumor DNA is collected at baseline and 6 weeks after last treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hangzhou Cancer Hospital Hangzhou Zhejiang China 310002

Sponsors and Collaborators

  • Hangzhou Cancer Hospital
  • Shanghai bokang bioengineering co., LTD

Investigators

  • Principal Investigator: Shixiu Wu, Doctor, Hangzhou Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shixiu Wu, President of Hangzhou Cancer Hospital, Hangzhou Cancer Hospital
ClinicalTrials.gov Identifier:
NCT03554889
Other Study ID Numbers:
  • HangzhouCH11
First Posted:
Jun 13, 2018
Last Update Posted:
Jun 13, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms
Nimotuzumab

Study Results

No Results Posted as of Jun 13, 2018