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)
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2021
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2021
CompletedFirst Posted
Study publicly available on registry
August 26, 2021
CompletedStudy Start
First participant enrolled
December 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedDecember 30, 2021
July 1, 2021
1.5 years
August 10, 2021
December 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Adverse Events
Adverse events are evaluated with CTCAE V5.0
12 months
Secondary Outcomes (3)
Overall response rate (ORR)
2 years
Event-free survival (EFS)
2 years
Cumulative incidence of relapse(CIR)
2 years
Study Arms (1)
CAR-T infusion
EXPERIMENTALFLT3 positive relapsed or refractory acute myeloid leukemia
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The First Affiliated Hospital of Soochow Universitylead
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical Schoolcollaborator
- The Second People's Hospital of Huai'ancollaborator
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.collaborator
Study Sites (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaowen Tang, Ph.D
The First Affiliated Hospital of Soochow University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2021
First Posted
August 26, 2021
Study Start
December 31, 2021
Primary Completion
June 30, 2023
Study Completion
June 30, 2025
Last Updated
December 30, 2021
Record last verified: 2021-07