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

Pilot Study of the Safety and Efficacy of Anti-FLT3 Chimeric Antigen Receptor Engineered T-Cells in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML)

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05023707

Enrollment

Registered

2021-08-26

Start date

2021-12-31

Completion date

2025-06-30

Last updated

2021-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

FLT3,CAR-T,AML

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.

Interventions

BIOLOGICALanti-FLT3 CAR-T

Single intravenous infusion of anti-FLT3 CAR-T cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Number of Adverse Events	12 months	Adverse events are evaluated with CTCAE V5.0

Secondary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactXiaowen Tang, Ph.D

xwtang1020@163.com(0086)51267781856

Backup ContactLin Yang, Ph.D

huimin.meng@persongen.com.cn(0086)18896802149

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026