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

NCT ID: NCT02862028

Last Updated: 2016-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-07-31

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.

Conditions

PD-1 Antibody; CAR-T Cells; Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HerinCAR-PD1 cells

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

Group Type: EXPERIMENTAL

HerinCAR-PD1 cells

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai International Medical Center

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naiyan Han

Role: STUDY_CHAIR

Shanghai International Medical Center

Locations

Shanghai International Medical Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Naiyan Han

Role: CONTACT

naiyan.han@simcgroup.com

+86 21 6023 6666

Facility Contacts

Naiyan Han

Role: primary

naiyan.han@simcgroup.com

+86 (0) 182 1766 2469

Other Identifiers

SIMC-20160101/02/03

Identifier Type: -

Identifier Source: org_study_id