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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02862028
• Other study ID #: SIMC-20160101/02/03
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 7, 2016
• Last updated: August 23, 2016
• Start date: August 2016
• Est. completion date: July 2018

Study information

• Verified date: August 2016
• Source: Shanghai International Medical Center
• Contact: Naiyan Han
• Phone: +86 21 6023 6666
• Email: naiyan.han[@]simcgroup.com
• Is FDA regulated: No
• Health authority: Ethics Committee:Shanghai International Medical Center Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai International Medical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai International Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)		2 years	No
Primary	Disease control rate,(DCR)		2 years	No
Primary	Overall survival		2 years	No
Primary	Progress-free survival(PFS)		2 years	No
Secondary	Quality of life	Questionnaire will be used.	2 years	No