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

Advanced Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02873390
• Other study ID #: NBWYKY2016-06-001/002/003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 15, 2016
• Last updated: October 6, 2016
• Start date: August 2016
• Est. completion date: July 2018

Study information

• Verified date: August 2016
• Source: Ningbo Cancer Hospital
• Contact: Bi Wang
• Phone: 86-13310088259
• Email: biwang0218[@]126.com
• Is FDA regulated: No
• Health authority: China:Ethics Committee: Ningbo No.5 Hospital (Ningbo Cancer Hospital) Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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 18~80 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.

Study Design

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

Related Conditions & MeSH terms

• Advanced Malignancies
• CAR-T Cells
• Neoplasms
• 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	Ningbo No.5 Hospital (Ningbo Cancer Hospital)	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo Cancer Hospital

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