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2015-10
2017-11
2018-11
20
NCT02580747
Chinese PLA General Hospital
Chinese PLA General Hospital
INTERVENTIONAL
Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART-meso
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-meso vector (referred to as CART-meso cells). II. Determine duration of in vivo survival of CART-meso cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-meso TCR (T-cell receptor) zeta:CD137 over time. SECONDARY OBJECTIVES: I. For patients with detectable disease, measure anti-tumor response due to CART-meso cell infusions. II. Estimate relative trafficking of CART-meso cells to tumor in bone marrow and lymph nodes. III. For patients with stored or accessible tumor cells determine tumor cell killing by CART-meso cells in vitro. IV. Determine if cellular or humoral host immunity develops against the murine anti-meso, and assess correlation with loss of detectable CART-meso (loss of engraftment). V. Determine the relative subsets of CART-meso T cells (Tcm, Tem, and Treg).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-10-19 | N/A | 2015-10-19 |
2015-10-19 | N/A | 2015-10-20 |
2015-10-20 | N/A | 2015-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: anti-meso CAR T cells Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. Patients receive anti-meso-CAR retroviral vector-transduced autologous-derived T cells on da | BIOLOGICAL: anti-meso-CAR vector transduced T cells
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Occurrence of Study related adverse events | defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical | Until week 24 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Anti-tumor responses to CART-meso cell infusions | up to 24 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Weidong Han, Dr. Phone Number: 86-10-13651392893 Email: hanwdrsw@sina.com |
Study Contact Backup Name: Yao Wang, Dr. Phone Number: 86-10-13311390785 Email: wangyao301@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
