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
1 other identifier
interventional
15
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2017
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2017
CompletedFirst Posted
Study publicly available on registry
June 21, 2017
CompletedStudy Start
First participant enrolled
September 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedNovember 19, 2024
November 1, 2024
7.6 years
June 16, 2017
November 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
efficacy: complete response; partial response; stable disease; progression disease; progression free survival.
2 years
Other Outcomes (3)
Progression free survival
2 years
Overall survival
2 years
Imaging evaluation before and after treatment
0 day and 60 day
Study Arms (1)
HEKT cell
EXPERIMENTALEnrolled patients will receive HEKT cell injection, 10-days interval, totally 3 times.
Interventions
3 cycles of HEKT cell treatment
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
- Shanghai Houchao Biotechnology Co., Ltdcollaborator
Study Sites (1)
Ruijin Hospital
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 16, 2017
First Posted
June 21, 2017
Study Start
September 14, 2017
Primary Completion
May 1, 2025
Study Completion
May 1, 2025
Last Updated
November 19, 2024
Record last verified: 2024-11