CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT

Shenzhen University

Status and phase: Unknown; Phase 1

Conditions: Lymphoma, B-Cell; Leukemia, Lymphocytic, Acute, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Treatments: Biological: CART19 cell and auto-HSCT

Study type: Interventional

Funder types: Other

Identifiers

NCT03685786

Weihong Chen06062018

Details and patient eligibility

About

The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT

Full description

The clinical study of the chimeric antigen receptor T cells (CART Cells) treatment for minimal residual disease(MRD) of B Cell Malignancies and then autologous hematopoietic stem cell transplantation(auto-HSCT).

Enrollment: 20 estimated patients

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with CD19+, B cell Acute Lymphocytic Leukemia(B-ALL), B cell Chronic Lymphocytic Leukemia(B-CLL), B cell Lymphoma，who have 0.01%≤MRD<10% during upfront treatment 2. Patients must be within 12 months of initial B-ALL, B-CLL, B cell Lymphoma diagnosis 3. Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis 4. Age 14 years to 75 years 5. Adequate organ function defined as:

2. AST and ALT ≤ 3 times upper limit of normal range for age,

3. Serum creatinine ≤ 1.6 mg/dl,

4. Direct bilirubin ≤2.0 mg/dl,

5. Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia,

6. Cardiac Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA. 6. Patients with CNS disease will be eligible if CNS disease is responsive to therapy 7. Expression of CD19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood 8. Adequate performance status defined as ECOG Performance Status 0 or 1 9. Provides written informed consent 10. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol

Exclusion criteria

1. Active, uncontrolled infection
2. Active hepatitis B or hepatitis C
3. HIV Infection
4. Class III/IV cardiovascular disability according to the New York Heart Association Classification
5. Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
6. Pregnant or nursing (lactating) women Patients with a known history or prior diagnosis of optic neuritis or other
7. immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Experimental: CART19 cell and auto-HSCT

Experimental group

Description:

CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.

Treatment:

Biological: CART19 cell and auto-HSCT