Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase: Unknown; Phase 1

Conditions: Acute Lymphoblastic Leukemia

Treatments: Biological: CAR-T cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02186860

307-CTC-CAR T

Details and patient eligibility

About

Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for fighting cancer. Many people do not respond to the standard treatments of ALL. One possible treatment is chimeric antigen receptor (CAR) modified T cell infusions. This study aims to evaluate the safety and efficacy of novel CARTs (targeting CD19) in the treatment of refractory or recurrent ALL.The investigators start Phase I study aimed to chemotherapy resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is to assess the safety and effectiveness of CAR-T cells in patients.

Full description

CAR-T has stronger effect of anti-tumor capacity. While people have been able to control the clinical complications now, so conducting CAR-T clinical trials has a strong demand and value. This study aims to evaluate the safety and efficacy of CD19-CART in treating refractory or recurrent ALL.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18-65 years
• Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as confirmed by flow cytometry
• Refractory or relapsed B cell-acute lymphoblastic leukemia
• No available curative treatment options (such as hematopoietic stem cell transplantation)
• Stage III-IV disease
• Creatinine < 2.5 mg/dl
• Aspartate transaminase-alanine transaminase ratio < 3x normal
• Bilirubin < 2.0 mg/dl
• Karnofsky performance status >= 60
• Expected survival time > 3 months
• Adequate venous access for apheresis
• Ability to understand and provide informed consent

Exclusion criteria

• Pregnant or lactating women
• Patients requiring T cell immunosuppressive therapy
• Active central nervous system leukemia
• Any concurrent active malignancies
• Patients with a history of a seizure disorder or cardiac disorder
• Patients with human immunodeficiency virus, hepatitis B or C infection
• Uncontrolled active infection

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

CAR-T cells

Experimental group

Description:

Targeting CD19

Treatment:

Biological: CAR-T cells