Anti-FLT3 CAR T-cell Therapy in FLT3 Positive Relapsed/Refractory Acute Myeloid Leukemia
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CAR-T infusion FLT3 positive relapsed or refractory acute myeloid leukemia |
Biological: anti-FLT3 CAR-T
Single intravenous infusion of anti-FLT3 CAR-T cells
|
Outcome Measures
Primary Outcome Measures
- Number of Adverse Events [12 months]
Adverse events are evaluated with CTCAE V5.0
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
FLT3 positive relapsed/refractory acute myeloid leukemia
-
Age 16-65 years.
-
Left ventricular ejection fractions ≥ 0.5 by echocardiography
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Creatinine < 1.5x upper limit of normal.
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Aspartate aminotransferase/aspartate aminotransferase ≤ 2.5x upper limit of normal
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Total bilirubin ≤ 1.5x upper limit of normal
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Karnofsky performance status ≥ 60
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Expected survival time ≥ 3 months (according to investigator's judgement)
Exclusion Criteria:
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Patients are pregnant or lactating
-
Uncontrolled active infection
-
Grade III/IV cardiovascular disability according to the New York Heart
-
Association Classification
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Active hepatitis B or hepatitis C infection
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China | 215006 |
Sponsors and Collaborators
- The First Affiliated Hospital of Soochow University
- 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.
Investigators
- Principal Investigator: Xiaowen Tang, Ph.D, The First Affiliated Hospital of Soochow University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021136