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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Treatment of Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia by Chimeric Antigen Receptor (CAR)-Modified T Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02186860
• Other study ID #: 307-CTC-CAR T
• Status: Recruiting
• Phase: Phase 1
• Start date: July 2016
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Yao Sun, M.D., Ph.D.
• Phone: +86-010-6694-7402
• Email: suny320[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• CAR-T cells
Given IV

Locations

Country	Name	City	State
China	Department of Hematopoietic Stem Cell Transplantation	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events	To evaluate the safety of CAR-T cells in adult patients with B-acute lymphoblastic leukemia	8 weeks
Secondary	Clinical responses to third generation CAR-T cells	To assess the anti-leukemic effect of CAR-T cells in adult patients with B cell-acute lymphoblastic leukemia	2 years