Study of High Efficient Killing Cell Therapy for Advanced NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HEKT cell.
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung Cancer. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase I Study of High Efficient Killing Cell Therapy for Advanced Non Small Cell Lung Cancer
Overview
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.
Interventions
- Biological HEKT cell
3 cycles of HEKT cell treatment
Primary outcome measures
- safety：safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment [Time frame: 2 years]
Secondary outcome measures (1)
- efficacy: complete response; partial response; stable disease; progression disease; progression free survival. [Time frame: 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital — Shanghai
Identifiers
NCT: NCT03193567 · RTS-005