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NCT Number: NCT03193567

Study of High Efficient Killing Cell Therapy for Advanced NSCLC

The purpose of this study to preliminarily evaluate the safety and efficacy of High Efficient Killing Cell Therapy for refractory and advanced non-small cell lung cancer

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ruijin Hospital

Shanghai, China

Location status: Recruiting

Location contact

Lei hai Du, Master

CONTACT

About this study

Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients' age from 18 years to 70 years.
  • Patients who have a life expectancy of at least 3 months.
  • pathologically confirmed non-small cell lung cancer.
  • failed in previous standard chemotherapy and targeted therapy.
  • Karnofsky performance status 0-1.
  • adequate organ functions.

Exclusion criteria

  • Pregnant and lactating women.
  • Patients with T cell lymphoma, syphilis, AIDS or combination
  • Patients with highly allergic or have a history of severe allergies
  • Patients with severe hepatic or renal dysfunction
  • Patients with severe autoimmune disease or who is being treated with immunosuppressive agents
  • Patients with severe infection not controlled or High fever
  • Patients with organ transplantation or waiting for organ transplantation.
  • Patients with brain metastasis
  • Patients with severe coagulopathy (e.g. hemophilia)
  • Patients without adequate ability to understand, sign informed consents and take part in the clinical research voluntarily.

Treatment and study plan

HEKT cell

Biological

3 cycles of HEKT cell treatment

Other names: High Efficient Killing Cell Therapy

Primary outcomes

  1. safety:safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment

    Time frame: 2 years

    Occurrence of study related adverse events as assessed by CTCAE v4.0

Secondary outcomes

  1. efficacy: complete response; partial response; stable disease; progression disease; progression free survival.

    Time frame: 2 years

    The efficacy of the treatment is assessed according to (RECIST1.1)

Other outcomes

  1. Progression free survival

    Time frame: 2 years

    Progression free survival is defined as the time from the day in which the patient is enrolled to the date on which tumor progresses or the date on which the patient dies for any cause.

  2. Overall survival

    Time frame: 2 years

    Overall survival is defined as the time from the day in which the patient is enrolled to the date on which the patient dies for any cause.

  3. Imaging evaluation before and after treatment

    Time frame: 0 day and 60 day

    the SUV index of PET-CT before cell injection and after the whole course of the treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Lei H Du, M.S

CONTACT

[email protected]

13918570392

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Shanghai Houchao Biotechnology Co., Ltd

Registry information

Official study title

Phase I Study of High Efficient Killing Cell Therapy for Advanced Non Small Cell Lung Cancer

Acronym: HEART

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jun 21, 2017
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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