Clinical trial NCT03599375: Immunotherapy With CD19 CART-cells for B Cell Acute Lymphoblastic Leukemia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Leukemia, B-Cell
Keywords: Chimeric Antigen Receptor-Modified T Cells
CART
Recurrent B Cell Acute Lymphoblastic Leukemia
refractory B Cell Acute Lymphoblastic Leukemia
ALL
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with recurrent or refractory CD19+ ALL receive CD19 CAR T-cell immunotherapy.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: overall response rate(ORR)
timeFrame: Participants will be followed for the duration of the treatment, with an expected average of 3 months.
Secondary outcomes:
measure: Progression free survival(PFS)
timeFrame: 15 years
measure: Overall survival(OS)
timeFrame: 15 years
Other outcomes:
Locations:
Study officials:
References: