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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02644655

Enrollment

Registered

2016-01-01

Start date

2015-09-30

Completion date

2017-09-30

Last updated

2016-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BIOLOGICALCD19-specific chimeric antigen receptor

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(5×105/kg，1×106/kg，3×106/kg).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Occurrence of adverse events and tumor response rate related to study drug	2 years

Countries

China

Contacts

Primary ContactQijun Qian, PHD

qianqj@sino-gene.cn+86-21-65580677

Backup ContactHuajun Jin, PHD

hj-jin@Hotmail.com+86-21-81875372

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026