Recurrent B-Cell Tumor Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | September 2017 |
| Est. primary completion date | March 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Eastern Hepatobiliary Surgery Hospital | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Second Military Medical University |
China,
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* Note: There are 14 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Occurrence of adverse events and tumor response rate related to study drug | 2 years | No |