CART19 in Adult Patients With Minimal Residual Disease During Upfront Treatment for ALL

Inclusion Criteria:

1. Patients with CD19+, B cell Acute Lymphoblastic Leukemia (B-ALL) who have
0.01%≤MRD<10% during upfront treatment

2. Patients must be within 18 months of initial ALL diagnosis

3. Age ≥18 years

4. Adequate organ function defined as:

1. Creatinine ≤ grade 2

2. ALT/AST ≤3x upper limit of normal range for age

3. Direct bilirubin ≤2.0 mg/dl

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

5. Cardiac Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA

5. Patients with CNS3 disease will be eligible if CNS disease is responsive to therapy.

6. Expression of CD19 on leukemic blasts demonstrated by flow cytometry or
immunohistochemistry of bone marrow or peripheral blood

7. Adequate performance status defined as ECOG Performance Status 0 or 1

8. Provides written informed consent

9. 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 (see Appendix 2)

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

7. Patients with a known history or prior diagnosis of optic neuritis or other
immunologic or inflammatory disease affecting the central nervous system, and
unrelated to leukemia or previous leukemia treatment.