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

Phase 1

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Biological: CAR-T cells

• Registration Number: NCT02186860
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-10
• Study Start: 2016-07
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-06
• Last Update Posted: 2021-02-10
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR-T cells	CAR-T cells	Targeting CD19

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	8 weeks	To evaluate the safety of CAR-T cells in adult patients with B-acute lymphoblastic leukemia

Secondary Outcome Measures

Name	Time	Method
Clinical responses to third generation CAR-T cells	2 years	To assess the anti-leukemic effect of CAR-T cells in adult patients with B cell-acute lymphoblastic leukemia

Trial Locations

Locations (1)

Department of Hematopoietic Stem Cell Transplantation; 🇨🇳 Beijing, China