Immunotherapy With CD19 CART-cells for B Cell Acute Lymphoblastic Leukemia

Leukemia, B-Cell Clinical Trial

Official title:

Safety and Clinical Activity of CD19 Chimeric Antigen Receptor T Cells in Treating Patients With Recurrent or Refractory CD19 Positive B Cell Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03599375
• Other study ID #: FJLU-002
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 1, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2019
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the safety and clinical activity of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in treating patients with recurrent or refractory CD19 positive B cell ccute lymphoblastic leukemia,and dynamically observe the changes of CAR-T in patients and the residual tumor.

Description:

In this single-center, open-label, single-arm, prospective clinical trial, a total of 20 recurrent or refractory CD19+ B cell acute lymphoblastic leukemia patients will be enrolled.After recruiting eligible patients,autologous peripheral blood mononuclear cells(PBMCs) will be purified from whole blood.The CD3+ T cells were subsequently selected and re-stimulated by anti-CD3 and anti-CD28 monoclonal antibodies.T cells will be transduced with lentiviral vector for the generation of the CD19 CART cell and administered by i.v. injection.The purpose of current study is to determine the safety and clinical efficacy of CD19 CAR T cells therapy in patients with recurrent or refractory CD19+ ALL.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

Inclusion Criteria:

• Recurrent or refractory B cell derived acute lymphoblastic leukemia (ALL)

• Patients who have failed at least one line of a standard treatment without effective treatment measures at present

• CD19 expression on the surface of B-ALL cells must be detected

• KPS>80

• Life expectancy >3 months

• Patients must have adequate cardiac function (no electrocardiogram with obvious abnormality, LVEF=50%),adequate pulmonary function as indicated by room air oxygen saturation of > 90%, and adequate renal function (Cr=2.5 times of the normal range)

• The alanine aminotransferase (ALT) and the aspartate aminotransferase (AST)= 3 times of the normal range, and the total bilirubin (TBIL)=2.0mg/dl(34.2umol/L)

• Hemoglobin(Hgb)=80g/L

• Without contraindication of apheresis and cell isolation

• Patients and their families volunteer to participate in the research with signed written informed consent

Exclusion Criteria:

.Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease; another severe and/or life-threatening medical disease.

• Evidence of uncontrolled current serious active infection

• HIV/HBV/HCV infection

• Pregnancy and nursing females

• Systemic glucocorticoid therapy within one week

Related Conditions & MeSH terms

• Burkitt Lymphoma
• Leukemia
• Leukemia, B-Cell
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• CD19-targeted CART cells
CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv.This is a second generation CRAT.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
jiuwei cui

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate(ORR)	ORR is defined as the proportion of partial responses plus complete responses.	Participants will be followed for the duration of the treatment, with an expected average of 3 months.
Secondary	Progression free survival(PFS)	Progression-free survival is defined as the time from enrollment to first observation of progression or date of death (from any cause).	15 years
Secondary	Overall survival(OS)	Overall survival, defined as the time from enrollment until death due to any cause. For patients who do not die, time to death will be censored at the time of last contact.	15 years