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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-12

Brief Summary

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This is a single center, single arm, open-label phase 2 study to determine the efficacy of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART19" cells) in adults with minimal residual disease (MRD) during upfront treatment for CD19+ acute lymphoblastic leukemia.

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Detailed Description

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Conditions

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Leukemia, Acute Lymphoblastic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CART19

CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion.

Group Type EXPERIMENTAL

CART 19

Intervention Type BIOLOGICAL

CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Subjects will receive 1-5 x 10\^8 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction: 1-5x10\^7 CART19 cells, Day 2, 30% fraction: 3x10\^7-1.5x10\^8 CART19 cells, Day 3, 60% fraction: 6x10\^7-3x10\^8 CART19 cells

Interventions

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CART 19

CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Subjects will receive 1-5 x 10\^8 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction: 1-5x10\^7 CART19 cells, Day 2, 30% fraction: 3x10\^7-1.5x10\^8 CART19 cells, Day 3, 60% fraction: 6x10\^7-3x10\^8 CART19 cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No