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Study of High Efficient Killing Cell Therapy for Advanced NSCLC (HEART)

Primary Purpose

Non Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HEKT cell
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HEKT cell

Arm Description

Enrolled patients will receive HEKT cell injection, 10-days interval, totally 3 times.

Outcomes

Primary Outcome Measures

safety：safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment
Occurrence of study related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

efficacy: complete response; partial response; stable disease; progression disease; progression free survival.
The efficacy of the treatment is assessed according to (RECIST1.1)

Full Information

First Posted
June 16, 2017
Last Updated
April 13, 2022
Sponsor
Ruijin Hospital
Collaborators
Shanghai Houchao Biotechnology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03193567
Brief Title
Study of High Efficient Killing Cell Therapy for Advanced NSCLC
Acronym
HEART
Official Title
Phase I Study of High Efficient Killing Cell Therapy for Advanced Non Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
Shanghai Houchao Biotechnology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HEKT cell
Arm Type
Experimental
Arm Description
Enrolled patients will receive HEKT cell injection, 10-days interval, totally 3 times.
Intervention Type
Biological
Intervention Name(s)
HEKT cell
Other Intervention Name(s)
High Efficient Killing Cell Therapy
Intervention Description
3 cycles of HEKT cell treatment
Primary Outcome Measure Information:
Title
safety：safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment
Description
Occurrence of study related adverse events as assessed by CTCAE v4.0
Time Frame
2 years
Secondary Outcome Measure Information:
Title
efficacy: complete response; partial response; stable disease; progression disease; progression free survival.
Description
The efficacy of the treatment is assessed according to (RECIST1.1)
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Progression free survival
Description
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.
Time Frame
2 years
Title
Overall survival
Description
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.
Time Frame
2 years
Title
Imaging evaluation before and after treatment
Description
the SUV index of PET-CT before cell injection and after the whole course of the treatment
Time Frame
0 day and 60 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei H Du, M.S
Phone
13918570392
Email
sealing821201@hotmail.com
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei hai Du, Master

12. IPD Sharing Statement

Learn more about this trial

Study of High Efficient Killing Cell Therapy for Advanced NSCLC

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