CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia

Shanghai Unicar-Therapy Bio-medicine Technology

Status and phase: Enrolling; Phase 1

Conditions: B-cell Acute Lymphocytic Leukemia

Treatments: Biological: CD19 CAR-T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03064269

UnicarTherapy

Details and patient eligibility

About

This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.

Full description

CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

Enrollment: 10 estimated patients

Sex: All

Ages: 10 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia
2. ALT/ AST 《 3x normal
3. Creatinine 《 3x normal
4. Age:10-60.
5. Signed informed consent

Exclusion criteria

1. Active hepatitis B , hepatitis C or HIV infection
2. Uncontrolled active infection
3. Pregnancy or breast-feeding women
4. Survival less than four weeks

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Arm 1

Experimental group

Description:

CD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia.

Treatment:

Biological: CD19 CAR-T cells