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PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor

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: NCT02873390
Recruitment Status : Unknown
Verified August 2016 by Ningbo Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : August 19, 2016
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
Ningbo Cancer Hospital

Tracking Information
First Submitted Date  ICMJE August 15, 2016
First Posted Date  ICMJE August 19, 2016
Last Update Posted Date October 7, 2016
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2016)
  • Objective response rate (ORR) [ Time Frame: 2 years ]
  • Disease control rate,(DCR) [ Time Frame: 2 years ]
  • Overall survival [ Time Frame: 2 years ]
  • Progress-free survival(PFS) [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02873390 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2016)
Quality of life [ Time Frame: 2 years ]
Questionnaire will be used.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor
Official Title  ICMJE A Clinical Study of PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor
Brief Summary

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

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.

Detailed Description A total of 20 patients may be enrolled over a period of 1-2 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • PD-1 Antibody
  • CAR-T Cells
  • Advanced Malignancies
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: HerinCAR-PD1 cells
Patients will receive 3 cycles of HerinCAR-PD1 cells treatment.
Intervention: Biological: HerinCAR-PD1 cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 16, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18~80 years old, male or female;
  2. Life expectancy≥6 months;
  3. ECOG score: 0-2;
  4. Advanced Solid Tumor were diagnosed by histology and cytology;
  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 EGFRVIII、IGF1R 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 x10*9/L, hemoglobin≥85g/L; lymphocyte ≥0.7×109/L, total bilirubin less than 2.5 times of the normal level; ALT and AST less than 2.5 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 4 months following the cells transfusion.
  10. Disease progression and the current treatment is invalid.
  11. The treatment effect is not ideal after receiving 2 line therapy at least and willing to join in clinical trials

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.
  6. Uncontrolled active infection.
  7. Serious chronic disease of critical organs such as kidney and liver. Kidney function more than CKD stage I,and liver function less than the Child - Pugh class B;
  8. Long-term use or being used of immunosuppressive drugs with autoimmune diseases
  9. Glucocorticoid is needed in a long term.
  10. Currently (within 30 days) enrolled in another clinical trial.
  11. Pregnancy or breastfeeding women.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02873390
Other Study ID Numbers  ICMJE NBWYKY2016-06-001/002/003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ningbo Cancer Hospital
Study Sponsor  ICMJE Ningbo Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jiangtao Wang Ningbo No.5 Hospital (Ningbo Cancer Hospital)
Study Chair: Huajun Jin Shanghai Cell Therapy Research Institute
Study Chair: Qijun Qian Shanghai Cell Therapy Research Institute
PRS Account Ningbo Cancer Hospital
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP