The Study of Targeted NY-ESO-1 T Cell Receptor (TCR) Genetic Modified Autologous T Cells Treatment of Advanced Solid Tumors

Advanced Malignant Solid Tumors Clinical Trial

Official title:

The Study of Targeted NY-ESO-1 T Cell Receptor (TCR) Genetic Modified Autologous T Cells Treatment of Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03047811
• Other study ID #: NY-TCR WXH 2016
• Status: Recruiting
• Phase: N/A
• First received: January 25, 2017
• Last updated: February 8, 2017
• Start date: August 26, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2017
• Source: Fudan University
• Contact: xiang hua wu, doctor
• Phone: 13482888167
• Email: xhwu2011[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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.

B. 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.

Related Conditions & MeSH terms

• Advanced Malignant Solid Tumors

Intervention

Other:
• TCR - T cell therapy
Low dose group: 1 x 10 ^8 /kg T cell total reinfusion. High dose groups: 10 x 10 ^ 8 / kgT cell total reinfusion.

Locations

Country	Name	City	State
China	Cancer hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival (OS)		From date of randomization until the date of date of death from any cause, whichever came first, assessed up to 36 months