NCT03554889

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2019

Completed
Last Updated

June 13, 2018

Status Verified

June 1, 2018

Enrollment Period

8 months

First QC Date

May 24, 2018

Last Update Submit

June 12, 2018

Conditions

Advanced CancerADCCNK Cell Mediated ImmunityNimotuzumabAdaptive Transfer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Response Rate

    3 months

Other Outcomes (3)

  • Progression free survival (PFS)

    1 year

  • Overall Survival (OS)

    1 year

  • Peripheral blood circulating tumor DNA

    6 weeks

Study Arms (1)

Experimental Group

EXPERIMENTAL

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 transferDrug: Nimotuzumab

Interventions

NK Cell adaptive transferBIOLOGICAL

Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer

Experimental Group
NimotuzumabDRUG

Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer

Experimental Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed recurrent or metastatic cancer
  • Measurable disease
  • Progressed after all standard treatment
  • ECOG performance status of 0 to 2
  • Expected life span ≥ 3 months
  • Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy
  • Major organs function normally
  • Women at pregnant ages should be under contraception
  • Willing and able to provide informed consent

You may not qualify if:

  • Other malignancy within 5 years prior to entry into the study, expect for treated non melanoma skin cancer and cervical carcinoma in situ
  • Poor vasculature
  • Disease to the central nervous system
  • Blood-borne infectious disease, eg. hepatitis B
  • History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
  • With other immune diseases, or chronic use of immunosuppressants or steroids
  • Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
  • Breastfeeding
  • Decision of unsuitableness by principal investigator or physician-in-charge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, 310002, China

Location

MeSH Terms

Interventions

nimotuzumab

Study Officials

  • Shixiu Wu, Doctor

    Hangzhou Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shixiu Wu, Doctor

CONTACT

+8657186826086wushixiu@medmail.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of Hangzhou Cancer Hospital

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 13, 2018

Study Start

August 1, 2018

Primary Completion

March 30, 2019

Study Completion

November 27, 2019

Last Updated

June 13, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)