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

Primary Purpose

Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
anti-FLT3 CAR-T
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring FLT3,CAR-T,AML

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAR-T infusion

Arm Description

FLT3 positive relapsed or refractory acute myeloid leukemia

Outcomes

Primary Outcome Measures

Number of Adverse Events
Adverse events are evaluated with CTCAE V5.0

Secondary Outcome Measures

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 (<1.0 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)
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)
time from the date of achievement of a remission until the date of relapse

Full Information

First Posted
August 10, 2021
Last Updated
December 29, 2021
Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
The First Affiliated Hospital with Nanjing Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Second People's Hospital of Huai'an, PersonGen BioTherapeutics (Suzhou) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05023707
Brief Title
Anti-FLT3 CAR T-cell Therapy in FLT3 Positive Relapsed/Refractory Acute Myeloid Leukemia
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 31, 2021 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
The First Affiliated Hospital with Nanjing Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Second People's Hospital of Huai'an, PersonGen BioTherapeutics (Suzhou) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
FLT3,CAR-T,AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAR-T infusion
Arm Type
Experimental
Arm Description
FLT3 positive relapsed or refractory acute myeloid leukemia
Intervention Type
Biological
Intervention Name(s)
anti-FLT3 CAR-T
Intervention Description
Single intravenous infusion of anti-FLT3 CAR-T cells
Primary Outcome Measure Information:
Title
Number of Adverse Events
Description
Adverse events are evaluated with CTCAE V5.0
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
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%.
Time Frame
2 years
Title
Event-free survival (EFS)
Description
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
Title
Cumulative incidence of relapse(CIR)
Description
time from the date of achievement of a remission until the date of relapse
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaowen Tang, Ph.D
Phone
(0086)51267781856
Email
xwtang1020@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Yang, Ph.D
Phone
(0086)18896802149
Email
huimin.meng@persongen.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaowen Tang, Ph.D
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaowen Tang, Ph.D
Phone
86-512677801856
Email
xwtang1020@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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