Trials Sponsors Conditions Drugs Pricing

Conditions

Lung Cancer, Nonsmall Cell, Recurrent

Outcome Measures

Primary Outcomes (1)

Number of participants with adverse events
To evaluate the safety and feasibility of the administration of anti-NY-ESO-1 TCR transduced T cells in patients with HLA-A2+ NY-ESO-1 expressing NSCLC.
30 Days

Secondary Outcomes (1)

Number of participants with clinical responses
270 Days

Study Arms (1)

Anti-NY-ESO-1 TCR-transduced T cells

EXPERIMENTAL

NYESO-1 TCR-T cell are prepared via lentiviral infection. DLT was administered in a dose escalation test according to the 3 + 3 design. Seven days prior to infusion of TCR-T cell, subjects receive cytoreductive chemotherapy with Cyclophosphamide (250-500mg/m2/day) and Fludarabine (25mg/m2/day) for 3 days. A single dose of Anti-NY-ESO-1 TCR transduced T cells (about 5×109) will be intravenously (i.v.) administered Additionally, following infusion of Anti-NY-ESO-1 TCR transduced T cells, IL-2 subcutaneous injections (500,000 IU/day) will be administered for 14 days concomitantly to each subject.

Drug: Cyclophosphamide and FludarabineBiological: Anti-NY-ESO-1 TCR transduced T cells

Interventions

Cyclophosphamide and FludarabineDrug

Seven days prior to infusion of TCR-T cell, subjects receive cytoreductive chemotherapy with cyclophosphamide (250-500mg/m2/day) plus fludarabine (25mg/m2/day) for 3 days.

Anti-NY-ESO-1 TCR-transduced T cells

Anti-NY-ESO-1 TCR transduced T cellsBiological

A single dose of Anti-NY-ESO-1 TCR transduced T cells (about 5×109) will be intravenously (i.v.) administered Additionally, following infusion of Anti-NY-ESO-1 TCR transduced T cells, IL-2 subcutaneous injections (500,000 IU/day) will be administered for 14 days concomitantly to each subject.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Cyclophosphamide and Fludarabine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

≥18 and ≤75 years old while signing the informed consent;
Sign an informed consent before undertaking any trial-related activities;

Sponsors & Collaborators

Xiangxue Life Science Research Center
Type not reportedcollaborator
Xiangxue Pharmaceutical
Othercollaborator
Guangdong Xiangxue Precision Medical Technology Co., Ltd.

Study Sites (1)

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

Shiyue Li, MDCONTACT8620-83062896 lishiyue@188.com

Shiyue Li, MDPRINCIPAL INVESTIGATOR

Chengzhi Zhou, MDPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Lung NeoplasmsRecurrence

Interventions

Cyclophosphamidefludarabine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Study Officials

Shiyue Li, MD
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
PRINCIPAL INVESTIGATOR
Chengzhi Zhou, MD
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiyue Li, MD

CONTACT

8620-83062896 lishiyue@188.com

Chengzhi Zhou, MD

CONTACT

8620-83062832

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD,Professor

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 24, 2017

You may not qualify if:

SCLC;
Received major surgery, conventional chemotherapy, large-area radiotherapy, immune therapy or any biological anti-tumor therapy within 4 weeks prior to the study;
Allergic to any components of the therapy;
Never recovered to \<2 grade CTCAE from prior surgery or treatment-related adverse events;
With two types of primary solid tumors;
Poorly managed hypertension (systolic blood pressure \>160 mmHg and / or diastolic blood pressure \> 90 mmHg) or clinically significant(for example, active) cardiovascular and cerebrovascular diseases such as cerebrovascular incident (within 6 months prior to signing the informed consent), myocardial infarction (within 6 months prior to signing the informed consent), unstable angina, grade II or above heart failure according to New York Heart Association Grading (See Appendix) Congestive, or severe arrhythmia can not be controlled by medication or has a potential impact on the study; With consecutive three times of obvious abnormality on electrocardiogram or average QTc interval ≥450 ms;
With other serious organic disease and/or mental illness;
With systemic active infections that need treatments, including active tuberculosis, HIV-positive or clinically active hepatitis A, B and C;
With autoimmune diseases: such as a history of inflammatory bowel disease (IBD) or other autoimmune diseases determined by the investigator to be unsuitable for the study (e.g. systemic lupus erythematosus (SLE), vasculitis, invasive pulmonary disease);
Within 4 weeks prior the infusion, received chronic systemic steroid cortisone, Hydroxyurea, immunomodulatory treatment (for example: Interleukin 2, alpha or gamma interferon, GCSF, mTOR inhibitors, cyclosporine etc.);
History of organ allografts, autologous / allogeneic stem cell transplantation, and renal replacement therapy;
With central nervous system metastasis. Patients with neurological symptoms need a brain CT/MRI examination to rule out brain metastases;
With uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or liver failure;
History of alcohol and / or drug abuse;
Pregnant or lactating female patients;
+3 more criteria

NY-ESO-1 TCR （TAEST16001）for Patients With Advanced NSCLC

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Anti-NY-ESO-1 TCR-transduced T cells

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Anti-NY-ESO-1 TCR-transduced T cells

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations