Study of High Efficient Killing Cell Therapy for Advanced NSCLC

Phase 1

Recruiting

• Conditions: Non Small Cell Lung Cancer
• Interventions: Biological: HEKT cell

• Registration Number: NCT03193567
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-18
• Study First Posted: 2017-06-21
• Study Start: 2017-09-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
safety：safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment	2 years	Occurrence of study related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, China