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

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

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

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Biological: HEKT cell

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lei H Du, M.S; Phone Number: 13918570392; Email: sealing821201@hotmail.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Ruijin Hospital
    • Contact: Lei hai Du, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEKT cell; Enrolled patients will receive HEKT cell injection, 10-days interval, totally 3 times.	Biological: HEKT cell; 3 cycles of HEKT cell treatment; Other Names: High Efficient Killing Cell Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy: complete response; partial response; stable disease; progression disease; progression free survival.	The efficacy of the treatment is assessed according to (RECIST1.1)	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	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 years
Overall survival	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.	2 years
Imaging evaluation before and after treatment	the SUV index of PET-CT before cell injection and after the whole course of the treatment	0 day and 60 day

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Shanghai Houchao Biotechnology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2017
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 18, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: RTS-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No