Advanced Malignant Solid TumorsNCT03047811
The Study of Targeted NY-ESO-1 T Cell Receptor (TCR) Genetic Modified Autologous T Cells Treatment of Advanced Solid Tumors
A study testing TCR - T cell therapy in people with Advanced Malignant Solid Tumors, run by Fudan University at 1 site in China.
Trial summary
The study of targeted NY-ESO-1 T cell receptor (TCR) genetic modified autologous T cells treatment of advanced solid tumors 1. The main purpose - security and ORR; 2. A secondary purpose - median progression-free surial;1 year, 2 years, total 5 years survival rate;The quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- TCR - T cell therapy
- 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
- 26 Aug 2016to 31 Dec 2017
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 3.1.1 volunteered for the clinical research and signed informed consent. 3.1.2 aged 18-70, expected lifetime > 3 months. 3.1.3 gender not limited. 3.1.4 late lung cancer (stage IIIb/IV), (IV) with esophageal carcinoma, and melanoma (advanced), no other effective cure Treatment method can be selected patients. 3.1.5 biopsy IHC confirmed positive expression, NY - ESO - 1 or 50% of the tumor cells IHC staining in 2 + and/or 3 +.Organization based on time in the group in the year before, can be a tumor tissue, can also be a pleural effusion cells
Who cannot join
- 3.2.1 this study used in the process of cell preparation ingredients allergy, such as penicillin, streptomycin.
- 3.2.2 used within a week of tyrosine kinase inhibitors (the treatment such as, for it), or other cancer drugs.
- 3.2.3 is systemic anti-cancer therapy, including immune therapy, such as accept the immune cells within a month back to lose Therapy or biological treatment.6 weeks used cancer associated with tumor immune single resistance (including the PD, PD - L1 and - 1 CTLA 4 single resistance). 3.2.4 have vital organs, such as cardiovascular, respiratory system disease, myocardial infarction, myocardial ischemia, the coronary artery bypass History or coronary ischemia symptoms, obstructive or restrictive lung disease. 3.2.5 the patient's immune tolerance is poor, may on the immune cells in treatment of the reaction of low or prone to toxic reactions.
- 3.2.6 always have autoimmune and immunodeficiency disease. 3.2.7 radiation pneumonitis. 3.2.8 depends on oxygen. 3.2.9 four weeks into the set of other therapeutic studies or clinical trials. 3.2.10 used experimental vaccine in two months 3.2.11 systemic corticosteroids used within two weeks, hydroxyurea or immune inhibitors (such as IL - 2, Interferons alpha, IFN - gamma, GSF, mTOR inhibitors, ring spore element, etc.).Recently or are using suction The sex hormone. 3.2.12 year have chronic or recurrent severe autoimmune diseases. 3.2.13 uncontrolled active infection. 3.2.14 2-4 acute or persistent during graft versus host disease (GVHD). 3.2.15 serious heart disease, after treatment of the disease is still unstable, into the group of the first six months after myocardial infarction, and congestion Heart failure, unstable angina, symptoms of pericardial effusion or unstable arrhythmia.
- 3.2.18 always suffer from other cancers, but does not include: A. basal cell carcinoma and squamous cell carcinoma after active treatment, the wound healed completely.
- the cervical or breast carcinoma in situ cure for at least three years. C. primary malignant tumors were removed completely, completely relieve five years or more.
- 3.2.19 accompanied by primary or secondary brain tumor patients. 3.2.20 the mentally disabled. 3.2.21 doubt or have alcohol and drug abuse history. 3.2.22 physicians determine cannot or may not be able to complete the test subjects.
- 3.2.23 any not listed may interfere with the patient to participate in the active disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Wu X hua, doctor, 13482888167, xhwu2011@yahoo.com
About this study
The study of targeted NY-ESO-1 T cell receptor (TCR) genetic modified autologous T cells treatment of advanced solid tumors
- The main purpose - security and ORR;
- A secondary purpose - median progression-free surial;1 year, 2 years, total 5 years survival rate;The quality of life.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- TCR - T cell therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCR - T cell therapyOther
Low dose group: 1 x 10 ^8 /kg T cell total reinfusion. High dose groups: 10 x 10 ^ 8 / kgT cell total reinfusion.
| Study group | Role | What they receive |
|---|---|---|
| TCR - T cell therapy | Experimental | Peripheral blood mononuclear cells collected: draw 100-150 ml of peripheral blood in patients and separate of the peripheral blood mononuclear cells, the total number of cells 1.5 * 10 ^ 7 / kg - 1 * 10 ^ 8 / kg Fludarabine 25 mg/m2 + NS 250 ml, ivgtt qdx5d, CTX 60 mg/kg + NS 250 ml, ivgtt qd x2d, should be in front of the TCR - T cells infusion of 4 days reinfusion the total number of T cells （1* 10 ^ 8 / kg - 10 * 10 ^ 8 / kg） in 3 days , infusion 10-15 minutes, should not be more than 20 minutes. Receives: Other: TCR - T cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
Measured: From date of randomization until the date of date of death from any cause, whichever came first, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start26 Aug 2016
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianghua Wu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047811
- Sponsor's protocol ID
- NY-TCR WXH 2016
- Status last verified
- Feb 2017
- First submitted
- 25 Jan 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Targeted NY-ESO-1 T Cell Receptor (TCR) Genetic Modified Autologous T Cells Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03047811
- Acronym / sponsor ID
- NY-TCR WXH 2016
- Conditions
- Advanced Malignant Solid Tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 26 Aug 2016 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- 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 study of targeted NY-ESO-1 T cell receptor (TCR) genetic modified autologous T cells treatment of advanced solid tumors
- The main purpose - security and ORR;
- A secondary purpose - median progression-free surial;1 year, 2 years, total 5 years survival rate;The quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TCR - T cell therapy | Experimental | Other: TCR - T cell therapyPeripheral blood mononuclear cells collected: draw 100-150 ml of peripheral blood in patients and separate of the peripheral blood mononuclear cells, the total number of cells 1.5 * 10 ^ 7 / kg - 1 * 10 ^ 8 / kg Fludarabine 25 mg/m2 + NS 250 ml, ivgtt qdx5d, CTX 60 mg/kg + NS 250 ml, ivgtt qd x2d, should be in front of the TCR - T cells infusion of 4 days reinfusion the total number of T cells （1* 10 ^ 8 / kg - 10 * 10 ^ 8 / kg） in 3 days , infusion 10-15 minutes, should not be more than 20 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 3.1.1 volunteered for the clinical research and signed informed consent. 3.1.2 aged 18-70, expected lifetime > 3 months. 3.1.3 gender not limited. 3.1.4 late lung cancer (stage IIIb/IV), (IV) with esophageal carcinoma, and melanoma (advanced), no other effective cure Treatment method can be selected patients. 3.1.5 biopsy IHC confirmed positive expression, NY - ESO - 1 or 50% of the tumor cells IHC staining in 2 + and/or 3 +.Organization based on time in the group in the year before, can be a tumor tissue, can also be a pleural effusion cells
Key exclusion criteria (8 listed)
- 3.2.1 this study used in the process of cell preparation ingredients allergy, such as penicillin, streptomycin.
- 3.2.2 used within a week of tyrosine kinase inhibitors (the treatment such as, for it), or other cancer drugs.
- 3.2.3 is systemic anti-cancer therapy, including immune therapy, such as accept the immune cells within a month back to lose Therapy or biological treatment.6 weeks used cancer associated with tumor immune single resistance (including the PD, PD - L1 and - 1 CTLA 4 single resistance). 3.2.4 have vital organs, such as cardiovascular, respiratory system disease, myocardial infarction, myocardial ischemia, the coronary artery bypass History or coronary ischemia symptoms, obstructive or restrictive lung disease. 3.2.5 the patient's immune tolerance is poor, may on the immune cells in treatment of the reaction of low or prone to toxic reactions.
- 3.2.6 always have autoimmune and immunodeficiency disease. 3.2.7 radiation pneumonitis. 3.2.8 depends on oxygen. 3.2.9 four weeks into the set of other therapeutic studies or clinical trials. 3.2.10 used experimental vaccine in two months 3.2.11 systemic corticosteroids used within two weeks, hydroxyurea or immune inhibitors (such as IL - 2, Interferons alpha, IFN - gamma, GSF, mTOR inhibitors, ring spore element, etc.).Recently or are using suction The sex hormone. 3.2.12 year have chronic or recurrent severe autoimmune diseases. 3.2.13 uncontrolled active infection. 3.2.14 2-4 acute or persistent during graft versus host disease (GVHD). 3.2.15 serious heart disease, after treatment of the disease is still unstable, into the group of the first six months after myocardial infarction, and congestion Heart failure, unstable angina, symptoms of pericardial effusion or unstable arrhythmia.
- 3.2.18 always suffer from other cancers, but does not include: A. basal cell carcinoma and squamous cell carcinoma after active treatment, the wound healed completely.
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 |
|---|---|---|
| TCR - T cell therapyLow dose group: 1 x 10 ^8 /kg T cell total reinfusion. High dose groups: 10 x 10 ^ 8 / kgT cell total reinfusion. | Other | TCR - T cell therapy |
Primary outcome
overall survival (OS)
Time frame: From date of randomization until the date of date of death from any cause, whichever came first, assessed up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Advanced Malignant Solid Tumors
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
Active, not recruitingPhase 2
Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With TSC1 or TSC2 Genetic Changes (MATCH - Subprotocol M)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCR - T cell therapy in people with Advanced Malignant Solid Tumors, run by Fudan University 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 1 inclusion and 8 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 9 Feb 2017. 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.
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 xiang hua wu, doctor (13482888167, xhwu2011@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (OS) (time frame: From date of randomization until the date of date of death from any cause, whichever came first, assessed up to 36 months). 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 9 Feb 2017.