CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Shanghai Unicar-Therapy Bio-medicine Technology

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Biological: CART-19

Study type

Interventional

Funder types

Industry

Identifiers

NCT03896854

UnicarTherapy20190308

Details and patient eligibility

About

This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19 positive relapsed or refractory acute myeloid leukemia.

Full description

The patients will receive infusion of CART cells targeting CD19 to confirm the safety and efficacy of CD19 CART Cells in relapsed or refractory acute myeloid leukemia.

Enrollment

15 estimated patients

Sex

All

Ages

6 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients with CD19+ relapsed/refractory acute myeloid leukemia
Age 6-65 years.
Left ventricular ejection fractions≥ 0.5 by echocardiography.
Creatinine < 1.6 mg/dL.
Aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal.
Bilirubin <2.0 mg/dL.
Karnofsky performance status ≥ 60
Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion criteria

Pregnant or lactating women.
Uncontrolled active infection.
Active hepatitis B or hepatitis C infection.
Class III/IV cardiovascular disability according to the New York Heart Association Classification.
HIV infection.
Patients with history of seizure
Active central nervous system leukemia