Carcinoma, Non-Small-Cell LungPhase 2NCT03432156
Autologous Tcm Cells Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Autologous Tcm cells immunotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Autologous Tcm cells immunotherapy combining surgery or chemotherapy could effectively prolong survival period and improve quality of life in patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Autologous Tcm cells immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2018to Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide written informed consent for the study.
- Subjects with pathologically confirmed stage II NSCLC.
- Subjects with stage II NSCLC had treatment with surgical resection and 4 cycles of postoperative adjuvant chemotherapy before the study.
- Karnofsky (KPS) ≥ 60.
- One or more Serum tumor markers such as carcinoembryonic antigen (CEA), CA125, cytokeratin-19 fragment (CYFRA21-1), neuron-specific enolase (NSE), pro-grp and angiopoietin-2 (Ang-2) are double higher than normal level or durative elevator on three consecutive tests.
- Adequate hematologic and end-organ function.
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- Subjects who could receive treatment with at least 3 cycles of autologous Tcm cells immunotherapy.
- Subjects must be received auxiliary examination and record these results in detail before and after immunotherapy.
- Subjects must meet the indications for autologous Tcm cells immunotherapy.
Who cannot join
- Subjects with lung nodules, lymph nodes, brain, liver, bone or adrenal metastasis before the study.
- Subjects who are using immunosuppressive agents or long-term immunosuppressive agents after organ transplantation.
- Subjects with severe abnormality of coagulation.
- History or any evidence of hemorrhage.
- Subjects with severe infection or high fever.
- Subjects with severe autoimmune diseases.
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- Subjects with persistent or intractable epilepsy.
- Subjects with merging other malignant neoplasms.
- Subjects with mental disorder.
- Subjects with heart, liver or kidney diseases.
- Major surgeries except for surgical resection of NSCLC were performed in 4 weeks before the study.
- Autologous bone marrow transplantation (ABMT) in 4 weeks before the study.
- Concurrent treatment or treatment on another study in 4 weeks before the study.
- Pregnancy or breast-feeding.
- There are drug abuse, medical treatment, mental illness and social disorders that would interfere with subjects' participation, or confound the results of the trial.
- Any condition that would interfere with or endanger the safety and compliance of subjects.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Jing Wang, +86-13801334518, wj7339@sina.com
About this study
Official title: Autologous Tcm Cells Immunotherapy in Patients With High-risk Recurrent Stage II Non-Small Cell Lung Cancer (NSCLC) After Postoperative Chemotherapy
Autologous Tcm cells immunotherapy combining surgery or chemotherapy could effectively prolong survival period and improve quality of life in patients.
Read the detailed description
Autologous central memory T cells (Tcm) cells immunotherapy is to collect patient's own immune cells in peripheral blood and then given back to the patient after amplified in vitro that can improve the anti-tumor immune response and is effective treatment of the cancer. Tcm cells are effective anti-tumor immune cells that exhibit the long-term survival and self-renewal capacity in vivo. Autologous Tcm cells immunotherapy combining surgery or chemotherapy could effectively prolong survival period and improve quality of life in patients.
Lung cancer is the leading cause of cancer related deaths, which account for one third of all deaths due to cancer worldwide. The most common histologic type of lung cancer is non-small-cell lung cancer (NSCLC) that is accounting for almost 85%. There are no targeted therapeutics in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy, therefore, autologous Tcm cells immunotherapy would be a safe and effective treatment.
The aim of this study is to assess the efficacy and safety of autologous Tcm cells immunotherapy in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy. Patients will be randomized 1:1 either to the experimental arm to receive 3 cycles of autologous Tcm cells immunotherapy or to the no intervention arm.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Autologous Tcm cells immunotherapy
- Keywords
- immunotherapy, NSCLC
- 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.
Autologous Tcm cells immunotherapyBiological
Autologous Tcm cells immunotherapy is to collect patient's own immune cells in peripheral blood and then given back to the patient after amplified in vitro.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | subjects who are treated with autologous Tcm cells immunotherapy Receives: Biological: Autologous Tcm cells immunotherapy |
| No intervention group | No intervention | subjects who are treated without autologous Tcm cells immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
This study will evaluate the clinical efficacy and safety of autologous Tcm cells immunotherapy in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy according to progression-free survival (PFS) .
Measured: 12 weeks
Secondary outcomes (1)
Overall Survival (OS)
This study will evaluate the overall survival of patients after autologous Tcm cells immunotherapy according to Overall Survival (OS).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start3 Apr 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: immunotherapy. subjects who are treated with autologous Tcm cells immunotherapy. No intervention group: subjects who are treated without autologous Tcm cells immunotherapy.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Newish Technology (Beijing) Co., Ltd.
- Responsible party
- Principal investigator, Jing Wang, Beijing Friendship Hospital
- Investigators
- Jing Wang, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432156
- Sponsor's protocol ID
- BeijingFH-JW-180202-1
- Status last verified
- Dec 2018
- First submitted
- 2 Feb 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Tcm Cells Immunotherapy in Patients With High-risk Recurrent Stage II Non-Small Cell Lung Cancer (NSCLC) After Postoperative Chemotherapy
- ClinicalTrials.gov ID
- NCT03432156
- Acronym / sponsor ID
- BeijingFH-JW-180202-1
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- immunotherapy, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Newish Technology (Beijing) Co., Ltd.
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 14 Feb 2018 (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.
Autologous Tcm cells immunotherapy combining surgery or chemotherapy could effectively prolong survival period and improve quality of life in patients.
Detailed description
Autologous central memory T cells (Tcm) cells immunotherapy is to collect patient's own immune cells in peripheral blood and then given back to the patient after amplified in vitro that can improve the anti-tumor immune response and is effective treatment of the cancer. Tcm cells are effective anti-tumor immune cells that exhibit the long-term survival and self-renewal capacity in vivo. Autologous Tcm cells immunotherapy combining surgery or chemotherapy could effectively prolong survival period and improve quality of life in patients.
Lung cancer is the leading cause of cancer related deaths, which account for one third of all deaths due to cancer worldwide. The most common histologic type of lung cancer is non-small-cell lung cancer (NSCLC) that is accounting for almost 85%. There are no targeted therapeutics in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy, therefore, autologous Tcm cells immunotherapy would be a safe and effective treatment.
The aim of this study is to assess the efficacy and safety of autologous Tcm cells immunotherapy in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy. Patients will be randomized 1:1 either to the experimental arm to receive 3 cycles of autologous Tcm cells immunotherapy or to the no intervention arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group: immunotherapy. subjects who are treated with autologous Tcm cells immunotherapy. No intervention group: subjects who are treated without autologous Tcm cells immunotherapy.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: Autologous Tcm cells immunotherapysubjects who are treated with autologous Tcm cells immunotherapy |
| No intervention group | No intervention | –subjects who are treated without autologous Tcm cells immunotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be willing and able to provide written informed consent for the study.
- Subjects with pathologically confirmed stage II NSCLC.
- Subjects with stage II NSCLC had treatment with surgical resection and 4 cycles of postoperative adjuvant chemotherapy before the study.
- Karnofsky (KPS) ≥ 60.
- One or more Serum tumor markers such as carcinoembryonic antigen (CEA), CA125, cytokeratin-19 fragment (CYFRA21-1), neuron-specific enolase (NSE), pro-grp and angiopoietin-2 (Ang-2) are double higher than normal level or durative elevator on three consecutive tests.
Key exclusion criteria (16 listed)
- Subjects with lung nodules, lymph nodes, brain, liver, bone or adrenal metastasis before the study.
- Subjects who are using immunosuppressive agents or long-term immunosuppressive agents after organ transplantation.
- Subjects with severe abnormality of coagulation.
- History or any evidence of hemorrhage.
- Subjects with severe infection or high fever.
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 |
|---|---|---|
| Autologous Tcm cells immunotherapyAutologous Tcm cells immunotherapy is to collect patient's own immune cells in peripheral blood and then given back to the patient after amplified in vitro. | Biological | Experimental group |
Primary outcome
Progression-free Survival (PFS)
Time frame: 12 weeks
This study will evaluate the clinical efficacy and safety of autologous Tcm cells immunotherapy in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy according to progression-free survival (PFS) .
1 secondary outcome
Overall Survival (OS)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jing Wang principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous Tcm cells immunotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Beijing Friendship 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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 19 Dec 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Wang (+86-13801334518, wj7339@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: 12 weeks). 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 Dec 2018.