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

NCT02873390 | Unknown Phase 1

• 1 other identifier: NBWYKY2016-06-001/002/003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PD-1 Antibody; CAR-T Cells; Advanced Malignancies

Keywords

PD-1 Antibody; CAR-T Cells; EGFR family; Advanced Malignancies

Outcome Measures

Primary Outcomes (4)

• Objective response rate (ORR)

  2 years

• Disease control rate,(DCR)

  2 years

• Overall survival

  2 years

• Progress-free survival(PFS)

  2 years

Secondary Outcomes (1)

• Quality of life

  2 years

Study Arms (1)

HerinCAR-PD1 cells

EXPERIMENTAL

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

Biological: HerinCAR-PD1 cells

Interventions

HerinCAR-PD1 cells 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.

HerinCAR-PD1 cells

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18\~80 years old, male or female;
• Life expectancy≥6 months;
• ECOG score: 0-2;
• Advanced Solid Tumor were diagnosed by histology and cytology;
• Enough venous channel,no other contraindications to the separation and collection of white blood cells;
• 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+;
• 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；
• Signed informed consent；
• 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.
• Disease progression and the current treatment is invalid.
• The treatment effect is not ideal after receiving 2 line therapy at least and willing to join in clinical trials

You may not qualify if:

• Expected Overall survival \< 6 months;
• Patients with uncontrolled hypertension,unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months.
• Abnormal lung function: FEV (forced expiratory volume) \< 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) \< 30% prediction, blood oxygen saturation \< 90%;
• Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
• Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
• Uncontrolled active infection.
• 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;
• Long-term use or being used of immunosuppressive drugs with autoimmune diseases
• Glucocorticoid is needed in a long term.
• Currently (within 30 days) enrolled in another clinical trial.
• Pregnancy or breastfeeding women.

Sponsors & Collaborators

• Ningbo Cancer Hospital: lead

Study Sites (1)

Ningbo No.5 Hospital (Ningbo Cancer Hospital)

Ningbo, Zhejiang, China

RECRUITING

Study Officials

• Jiangtao Wang

  Ningbo No.5 Hospital (Ningbo Cancer Hospital)

  STUDY DIRECTOR

• Huajun Jin

  Shanghai Cell Therapy Research Institute

  STUDY CHAIR

• Qijun Qian

  Shanghai Cell Therapy Research Institute

  STUDY CHAIR

Central Study Contacts

Bi Wang

CONTACT

86-13310088259; biwang0218@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 19, 2016
• Study Start: August 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 7, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)