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PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor (Lung, Liver and Stomach)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02862028
Recruitment Status : Unknown
Verified August 2016 by Shanghai International Medical Center.
Recruitment status was:  Recruiting
First Posted : August 10, 2016
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Shanghai International Medical Center

Brief Summary:

Objectives:

To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat relapsed or refractory cancer.

Eligibility:

Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with relapsed or refractory cancer that has not responded to or has relapsed after standard treatment.


Condition or disease Intervention/treatment Phase
PD-1 Antibody CAR-T Cells Advanced Solid Tumor Biological: HerinCAR-PD1 cells Phase 1 Phase 2

Detailed Description:
A total of 20 patients may be enrolled over a period of 1-2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor (Lung, Liver and Stomach)
Study Start Date : August 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HerinCAR-PD1 cells
Patients will receive 3 cycles of HerinCAR-PD1 cells treatment.
Biological: HerinCAR-PD1 cells
herinCAR-PD1 cells transfusion: (1-5×107/kg herinCAR-PD1 + physiological saline + 0.25% human alloalbumin) 300ml for each infusion. IV (in the vein) for each infusion, 2 cycles, each cycle received one infusions on day 21, 43.




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 2 years ]
  2. Disease control rate,(DCR) [ Time Frame: 2 years ]
  3. Overall survival [ Time Frame: 2 years ]
  4. Progress-free survival(PFS) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 2 years ]
    Questionnaire will be used.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18~65 years old, male or female;
  2. Life expectancy≥6 months;
  3. ECOG score: 0-3;
  4. Advanced solid tumor (lung cancer, gastric cancer, liver cancer) were diagnosed by pathological or clinical physicians;
  5. Enough venous channel, no other contraindications to the separation and collection of white blood cells;
  6. Immunohistochemistry and RT-PCR technology will be used to determine the positive EGFR family (including EGFR, HER2, HER4) and IGFR1 protein. At least one protein expressed in immunohistochemical tumor tissue should be no less than grade 2 or 2+ scores. The levels of protein are defined as follows: (according to cell staining) : grade 0: without staining; grade 1: 1-25%; grade 2: 26-50% and grade 3: 51-100%; (According to the intensity): negative; 1+; 2+ and 3+;
  7. Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;
  8. Signed informed consent;
  9. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria:

  1. Expected Overall survival < 6 months;
  2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months.
  3. Abnormal lung function: FEV (forced expiratory volume) < 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) < 30% prediction, blood oxygen saturation < 90%;
  4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
  5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862028


Contacts
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Contact: Naiyan Han +86 21 6023 6666 naiyan.han@simcgroup.com

Locations
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China, Shanghai
Shanghai International Medical Center Recruiting
Shanghai, Shanghai, China, 201318
Contact: Naiyan Han    +86 (0) 182 1766 2469    naiyan.han@simcgroup.com   
Sponsors and Collaborators
Shanghai International Medical Center
Investigators
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Study Chair: Naiyan Han Shanghai International Medical Center

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Responsible Party: Shanghai International Medical Center
ClinicalTrials.gov Identifier: NCT02862028     History of Changes
Other Study ID Numbers: SIMC-20160101/02/03
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016
Keywords provided by Shanghai International Medical Center:
PD-1 antibody
CAR-T cells
EGFR family
advanced solid tumor
Additional relevant MeSH terms:
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Neoplasms
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs