Immunotherapy of Advanced Cancer Using a Combination Nimotuzumab and NK Cells

June 12, 2018 updated by: Shixiu Wu, Hangzhou Cancer Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310002
        • Hangzhou Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 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
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: 3 months
Response will be evaluated according to RECIST v1.1
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 1 year
From date of randomization until the date of first documented progression or date of death from any cause
1 year
Overall Survival (OS)
Time Frame: 1 year
The time from randomization to death from any cause
1 year
Peripheral blood circulating tumor DNA
Time Frame: 6 weeks
Peripheral circuiting tumor DNA is collected at baseline and 6 weeks after last treatment
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou Cancer Hospital

Collaborators

Shanghai bokang bioengineering co., LTD

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2018

Primary Completion (ANTICIPATED)

March 30, 2019

Study Completion (ANTICIPATED)

November 27, 2019

Study Registration Dates

First Submitted

May 24, 2018

First Submitted That Met QC Criteria

June 12, 2018

First Posted (ACTUAL)

June 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 13, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HangzhouCH11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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