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

Phase 1

Recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Biological: anti-FLT3 CAR-T

• Registration Number: NCT05023707
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-26
• Last Update Submitted: 2021-12-29
• Last Update Posted: 2021-12-30
• Study Start: 2021-12-31
• Primary Completion: 2023-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR-T infusion	anti-FLT3 CAR-T	FLT3 positive relapsed or refractory acute myeloid leukemia

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	12 months	Adverse events are evaluated with CTCAE V5.0

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	2 years	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 (\<1.0 x 109/L) or thrombocytopenia (\<100 x 109/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%.
Event-free survival (EFS)	2 years	time from enrollment to the date of primary refractory disease, or relapse from CR or CRi, or death from any cause
Cumulative incidence of relapse(CIR)	2 years	time from the date of achievement of a remission until the date of relapse

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China