CD38-targeted Chimeric Antigen Receptor T Cell (CART) in Relapesd or Refractory Acute Myeloid Leukemia

Soochow University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Biological: CART-38

Study type

Interventional

Funder types

Other

Identifiers

NCT04351022

UnicarTherapy2020001

Details and patient eligibility

About

This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD38 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD38 positive relapsed or refractory acute myeloid leukemia.

Full description

The patients will receive infusion of CAR T-cells targeting CD38 to confirm the safety and efficacy of CD38 CAR T-Cells in relapsed or refractory acute myeloid leukemia.

Enrollment

20 estimated patients

Sex

All

Ages

6 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

CD38 positive 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
Total bilirubin <2.0 mg/dL
karnofsky performance status ≥ 60
expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion criteria

patients are pregnant or lactating
uncontrolled active infection
class III/IV cardiovascular disability according to the New York Heart Association Classification
active hepatitis B or hepatitis C infection
patients with HIV infection
patients with history of seizure
active central nervous system leukemia