Clinical trial NCT02644655: Immunotherapy Using Autologous T Cell-Engineered With CD19-specific Chimeric Antigen Receptor for the Treatment of Recurrent /Refractory B Cell Leukemia
Official title: A Clinical Study Using Autologous T Cell Engineered With Chimeric Antigen Receptor Targeting to CD19（Cluster of Differentiation Antigen 19) in Treating Patients With Recurrent /Refractory B Cell Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Recurrent B-Cell Tumor
Refractory B-Cell Tumor
Keywords: Recurrent B-Cell Tumor
Refractory B-Cell Tumor
New Cluster of Differentiation Antigen 19-chimeric Antigen Receptor T Cells
safety
prognosis
Lead sponsor: Second Military Medical University
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objectives:

The purpose of this study is to evaluate the safety and prognosis of New Cluster of Differentiation Antigen 19-chimeric Antigen Receptor T (nCAR19-T) Cells in the treatment of recurrent/refractory B-cell tumor and the Optimal dosage of nCAR19-T cell therapy.

Methods:

This study designs a novel therapy using nCAR19-T. 20 patients will be enrolled. Cyclophosphamide 500 mg - 2000 mg/m2 (day 2) with or without Fludarabine 30 mg/m2 /day, 4 days (day-6,-5,-4,-3); nCAR19-T transfusion：day 0(5×10※5/kg，1×10※6/kg，3×10※6/kg). According to the National Cancer Institute (NCI) standard (CTCAE), they will be observed 24 weeks long. Follow-up survey after the clinical study: within 1 months, once a week; then once a month for 1 years; and then once a year, a total of 15 years.

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

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old, male or female
2. Karnofsky≥60%
3. At least 2 courses of chemotherapy were performed
4. Creatinine is less than 2.5mg/dL;alanine aminotransferase (ALT) / aspartate aminotransferase(AST) less than 3 times of the normal bilirubin is less than 3mg/dL
5. Adequate venous access, isolation, and white blood cell production without other taboos
6. Signed informed consent
7. Patients with fertility are willing to use contraceptive method.
8. At least two months after infusion of T cells

Exclusion Criteria:

1. Need to use glucocorticoid therapy
2. Need immunotherapy
3. Creatinine \> 2.5mg/dL; ALT / AST \> 5 times of the normal; bilirubin \> 3mg/dL
4. Forced expiratory volume at one second (FEV1)\<2 L,diffusing capacity of the lung for carbon monoxide (DLCO)\<40%
5. congestive cardiac failure (III or IV, NYHA); Significant hypotension; Coronary heart disease Can not be controlled; DLCO\<40%
6. human immunodeficiency virus (HIV), hepatitis B virus (HBV),hepatitis C virus (HCV) patients
7. Had received gene therapy
8. Significant encephalopathy / new focal neurologic impairment
9. Blood culture positive or radiographic evidence of infection
10. Other drugs, or other biological treatment, chemotherapy or radiotherapy are performed within a month
11. The history of allergic reactions in cell therapy and cetuximab similar compounds.

Primary outcomes:
measure: Occurrence of adverse events and tumor response rate related to study drug
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Qijun Qian, PHD
role: STUDY_CHAIR
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