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

Phase 1

• Conditions: Advanced Solid Tumor; PD-1 Antibody; CAR-T Cells
• Interventions: Biological: HerinCAR-PD1 cells

• Registration Number: NCT02862028
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-08-07
• Study First Submitted QC: 2016-08-07
• Study First Posted: 2016-08-10
• Last Update Submitted: 2016-08-23
• Last Update Posted: 2016-08-25
• Primary Completion: 2018-03
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HerinCAR-PD1 cells	HerinCAR-PD1 cells	Patients will receive 3 cycles of HerinCAR-PD1 cells treatment.

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	2 years
Progress-free survival(PFS)	2 years
Disease control rate,(DCR)	2 years
Overall survival	2 years

Secondary Outcome Measures

Name	Time	Method
Quality of life	2 years	Questionnaire will be used.

Trial Locations

Locations (1)

Shanghai International Medical Center; 🇨🇳 Shanghai, Shanghai, China