Clinical Trials /

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

NCT02873390

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Unknown status

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor
  • Official Title: A Clinical Study of PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor

Clinical Trial IDs

  • ORG STUDY ID: NBWYKY2016-06-001/002/003
  • NCT ID: NCT02873390

Conditions

  • PD-1 Antibody
  • CAR-T Cells
  • Advanced Malignancies

Interventions

DrugSynonymsArms
HerinCAR-PD1 cellsHerinCAR-PD1 cells

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
HerinCAR-PD1 cellsExperimentalPatients will receive 3 cycles of HerinCAR-PD1 cells treatment.

    Eligibility Criteria

            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 EGFRVIIIIGF1R 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.
          
    Maximum Eligible Age:65 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Objective response rate (ORR)
    Time Frame:2 years
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Quality of life
    Time Frame:2 years
    Safety Issue:
    Description:Questionnaire will be used.

    Details

    Phase:Phase 1/Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Ningbo Cancer Hospital

    Trial Keywords

    • PD-1 Antibody
    • CAR-T Cells
    • EGFR family
    • Advanced Malignancies

    Last Updated

    October 6, 2016