Anti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)

Soochow University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Biological: anti-CLL1 CART

Study type: Interventional

Funder types: Other

Identifiers

NCT04884984

UnicarTherapy2021001

Details and patient eligibility

About

This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of anti-CLL1 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CLL1 positive relapsed or refractory acute myeloid leukemia.

Full description

The patients will receive infusion of anti-CLL1 CAR T-cells to confirm the safety and efficacy of anti-CLL1 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

• CLL1 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

CLL1 positive relapsed or refractory acute myeloid leukemia

Experimental group

Treatment:

Biological: anti-CLL1 CART