Non Small Cell Lung CancerPhase 1HEARTNCT03193567
Study of High Efficient Killing Cell Therapy for Advanced NSCLC
A Phase 1 study testing HEKT cell in people with Non Small Cell Lung Cancer, run by Ruijin Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- HEKT cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2017to 1 May 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- HEKT cell
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEKT cellBiological
Also called High Efficient Killing Cell Therapy
3 cycles of HEKT cell treatment
| Study group | Role | What they receive |
|---|---|---|
| HEKT cell | Experimental | Enrolled patients will receive HEKT cell injection, 10-days interval, totally 3 times. Receives: Biological: HEKT cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
efficacy: complete response; partial response; stable disease; progression disease; progression free survival.
The efficacy of the treatment is assessed according to (RECIST1.1)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start14 Sep 2017
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Houchao Biotechnology Co., Ltd
- Responsible party
- Principal investigator, Hecheng Li M.D., Ph.D, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193567
- Sponsor's protocol ID
- RTS-005
- Acronym
- HEART
- Status last verified
- Nov 2024
- First submitted
- 16 Jun 2017
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of High Efficient Killing Cell Therapy for Advanced Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03193567
- Acronym / sponsor ID
- HEART / RTS-005
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Houchao Biotechnology Co., Ltd
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEKT cell | Experimental | Biological: HEKT cellEnrolled patients will receive HEKT cell injection, 10-days interval, totally 3 times. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEKT cellAlso: High Efficient Killing Cell Therapy3 cycles of HEKT cell treatment | Biological | HEKT cell |
Primary outcome
safety：safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment
Time frame: 2 years
Occurrence of study related adverse events as assessed by CTCAE v4.0
1 secondary outcome
efficacy: complete response; partial response; stable disease; progression disease; progression free survival.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HEKT cell in people with Non Small Cell Lung Cancer, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei H Du, M.S (13918570392, sealing821201@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety：safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.