Anti-FLT3 CAR T-cell Therapy in FLT3 Positive Relapsed/Refractory Acute Myeloid Leukemia

Soochow University

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Biological: anti-FLT3 CAR-T

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05023707

2021136

Details and patient eligibility

About

This is a prospective,open-label, phase1/2 study to evaluate the safety and efficacy of anti-FLT3 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of FLT3 positive relapsed or refractory acute myeloid leukemia.

Full description

The patients will receive infusion of anti-FLT3 CAR T-cells targeting FLT3 to evaluate the safety and efficacy of anti-FLT3 CAR T-Cells in relapsed or refractory acute myeloid leukemia.

Enrollment

5 estimated patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

FLT3 positive relapsed/refractory acute myeloid leukemia
Age 16-65 years.
Left ventricular ejection fractions ≥ 0.5 by echocardiography
Creatinine < 1.5x upper limit of normal.
Aspartate aminotransferase/aspartate aminotransferase ≤ 2.5x upper limit of normal
Total bilirubin ≤ 1.5x upper limit of normal
Karnofsky performance status ≥ 60
Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion criteria

Patients are pregnant or lactating
Uncontrolled active infection
Grade 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 a history of seizure
Patients with other contraindications considered unsuitable for participation in this study (according to investigator's judgement)