Study of High Efficient Killing Cell Therapy for Advanced NSCLC

Non Small Cell Lung Cancer Clinical Trial

— HEART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03193567
• Other study ID #: RTS-005
• Status: Recruiting
• Phase: Phase 1
• Start date: September 14, 2017
• Est. completion date: May 1, 2025

Study information

• Verified date: November 2023
• Source: Ruijin Hospital
• Contact: Lei H Du, M.S
• Phone: 13918570392
• Email: sealing821201[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Biological:
• HEKT cell
3 cycles of HEKT cell treatment

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	Shanghai Houchao Biotechnology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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