Immunotherapy Using Autologous T Cell-Engineered With CD19-specific Chimeric Antigen Receptor for the Treatment of Recurrent /Refractory B Cell Leukemia

Phase 1

• Conditions: Recurrent B-Cell Tumor; Refractory B-Cell Tumor
• Interventions: Biological: CD19-specific chimeric antigen receptor

• Registration Number: NCT02644655
• Lead Sponsor: Second Military Medical University

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.

Study Timeline

• Status Verified: 2015-09
• Study Start: 2015-09
• Study First Submitted: 2015-12-12
• Study First Submitted QC: 2015-12-31
• Last Update Submitted: 2015-12-31
• Study First Posted: 2016-01-01
• Last Update Posted: 2016-01-01
• Primary Completion: 2017-03
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD19-specific chimeric antigen receptor	CD19-specific chimeric antigen receptor	After pretreatment, cluster of differentiation antigen 19 (CD19)-specific chimeric antigen receptor will be transfused.

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events and tumor response rate related to study drug	2 years

Trial Locations

Locations (1)

Eastern Hepatobiliary Surgery Hospital; 🇨🇳 Shanghai, China