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.
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
Drug | Synonyms | Arms |
---|
HerinCAR-PD1 cells | | HerinCAR-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
Name | Type | Description | Interventions |
---|
HerinCAR-PD1 cells | Experimental | Patients 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 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.
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: | Unknown status |
Lead Sponsor: | Ningbo Cancer Hospital |
Trial Keywords
- PD-1 Antibody
- CAR-T Cells
- EGFR family
- Advanced Malignancies
Last Updated
October 7, 2016