Know Cancer

forgot password

Clinical Study of Chimeric EGFR Antigen Receptor-modified T Cells in Chemotherapy Refractory Advanced Solid Tumors

Phase 1/Phase 2
18 Years
80 Years
Open (Enrolling)
Advanced EGFR-positive Solid Tumors

Thank you

Trial Information

Clinical Study of Chimeric EGFR Antigen Receptor-modified T Cells in Chemotherapy Refractory Advanced Solid Tumors


I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced
with the anti-EGFR vector (referred to as CART-EGFR cells).

II. Determine duration of in vivo survival of CART-EGFR cells. RT-PCR (reverse transcription
polymerase chain reaction) analysis of whole blood will be used to detect and quantify
survival of CART-EGFR TCR zeta:CD137 and TCR (T-cell receptor) zeta cells over time.


I. For patients with detectable disease, measure anti-tumor response due to CART-EGFR cell

II. Estimate relative trafficking of CART-EGFR cells in tumor bed.

III. Determine if cellular or humoral host immunity develops against the murine anti-EGFR,
and assess correlation with loss of detectable CART-EGFR (loss of engraftment).

IV. Determine the relative subsets of CART-EGFR T cells (Tcm, Tem, and Treg).

OUTLINE: Patients are assigned to 1 group according to order of enrollment.

Patients receive anti-EGFR-CAR (coupled with CD137 and CD3 zeta signalling
domains)vector-transduced autologous T cells on days 0,1, and 2 in the absence of
unacceptable toxicity.

After completion of study treatment, patients are followed intensively for 6 months, every 3
months for 2 years, and annually thereafter for 13 years.

Estimate relative trafficking of CART-EGFR cells in peripheral blood.

Inclusion Criteria:

1. Chemotherapy refractory EGFR-positive non-small cell lung cancer, colorectal cancer
with liver metastasis,and chemotherapy resistant or relapsed ovary cancer.

2. Relapsed patients after anti-EGFR using antibody or kinase inhibitor therapy.

3. Patients must be 18 years of age or older.

4. Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of

5. Patients must have evidence of adequate bone marrow reserve, hepatic and renal
function as evidenced by the following laboratory parameters:

Absolute neutrophil count greater than 1500/mm3. Platelet count greater than
100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to
meet this parameter).

Total bilirubin < 1.5 times upper limits of normal. Serum creatinine less than or
equal to 1.6 mg/ml or the creatinine clearance must be greater than 70

6. Seronegative for HIV antibody.

7. Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.

8. Patients must be willing to practice birth control during and for four months
following treatment.NOTE:women of child-bearing age must have evidence of negative
pregnancy test.

9. Patients must be willing to sign an informed consent.

Exclusion Criteria:

1. Patients with life expectancy less than 12 months will be excluded.

2. Patients with uncontrolled hypertension (> 160/95), unstable coronary disease
evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive
heart failure (> New York Heart Association Class II), or myocardial infarction
within 6 months of study will be excluded.

3. Patients with any of the following pulmonary function abnormalities will be excluded:
FEV(forced expiratory volume), < 30% predicted; DLCO (diffusing capacity of lung for
carbon monoxide) < 30% predicted (post-bronchodilator); Oxygen Saturation less than
90% on room air.

4. Patients with severe liver and kidney dysfunction or consciousness disorders will be

5. Pregnant and/or lactating women will be excluded.

6. Patients with active infections, including HIV, will be excluded, due to unknown
effects of the vaccine on lymphoid precursors.

7. Patients with any type of primary immunodeficiencies will be excluded from the study.

8. Patients requiring corticosteroids (other than inhaled) will be excluded.

9. Patients with history of T cell tumors will be excluded.

10. Patients who are participating or participated any other clinical trials in latest 30
days will be excluded.

Type of Study:


Study Design:

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

Outcome Measure:

Occurrence of study related adverse events

Outcome Time Frame:

Until week 24

Safety Issue:


Principal Investigator

weidong han, Dr.

Investigator Role:

Study Chair

Investigator Affiliation:

Chinese PLA General Hospital


China: Ethics Committee

Study ID:




Start Date:

May 2013

Completion Date:

December 2017

Related Keywords:

  • Advanced EGFR-positive Solid Tumors
  • chemotherapy and/or EGFR-antibody/kinase inhibitor therapy refractory solid tumors
  • Neoplasms