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

The First Affiliated Hospital of Soochow University20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia

Interventions

anti-CLL1 CARTBIOLOGICAL

Split intravenous infusion of anti-CLL1 CAR T cells \[dose escalating infusion of (5-20)x10\^6 anti-CLL1 CAR T cells/kg\].

Eligibility

Sex: ALLMin age: 6 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

Number of Adverse Events

Adverse events are evaluated with CTCAE V5.0

Time frame: 12 months

Secondary Outcomes

Overall response rate (ORR)

ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0x 10\^9/L; platelet count \>100x10\^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (\<1.0x10\^9/L) or thrombocytopenia (\<100x10\^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.

Time frame: 2 years

overall survival (OS)

The date of enrollment to the date of death from any cause

Time frame: 2 years

Event-free survival (EFS)

Time from enrollment to the date of primary refractory disease, or relapse from CR or CRi, or death from any cause

Time frame: 2 years

Cumulative incidence of relapse(CIR)

Time from the date of achievement of a remission to the date of relapse

Time frame: 2 years