Actively Recruiting
Anti-FLT3 CAR-T Cell (TAA05 Cell Injection) in the Treatment of Relapsed / Refractory Acute Myeloid Leukemia
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2022-07-06
12
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
P
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a clinical trial of Anti-FLT3 CAR-T Cell (TAA05 Cell Injection) in the treatment of patients with relapsed / refractory acute myeloid leukemia. The purpose is to evaluate the safety and efficacy of anti-FLT3 CAR-T cells in patients with relapsed / refractory acute myeloid leukemia.
CONDITIONS
Official Title
Anti-FLT3 CAR-T Cell (TAA05 Cell Injection) in the Treatment of Relapsed / Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years old, any gender
- FLT-3 positive acute myeloid leukemia
- Expected survival time of more than 3 months
- ECOG performance score between 0 and 2
- Relapsed or refractory AML after standard treatment, meeting at least one of the following: presence of 5% or more leukemia cells in bone marrow after remission, ineffective after two treatment courses, relapse within 12 months after remission, relapse after 12 months but unresponsive to chemotherapy, multiple relapses, or persistent extramedullary leukemia
- Kidney function with creatinine less than or equal to 1.5 times upper limit of normal (ULN)
- Heart function with left ventricular ejection fraction at least 50%, no significant pericardial effusion, and normal ECG
- Blood oxygen saturation above 92%
- Liver function with total bilirubin less than or equal to 2 times ULN, ALT and AST less than or equal to 2.5 times ULN (up to 5 times ULN if caused by disease-related factors)
- Blood clotting function with PT/INR and PTT less than or equal to 1.5 times ULN
- Ability to understand the trial and provide informed consent
You will not qualify if you...
- Having malignant tumors other than acute myeloid leukemia within 5 years before screening, except certain fully treated local cancers
- Positive for hepatitis B surface antigen or core antibody with abnormal HBV DNA, positive hepatitis C antibody and RNA, HIV positive, CMV DNA positive, or syphilis positive
- Severe heart diseases such as unstable angina, recent myocardial infarction within 6 months, severe heart failure (NYHA grade III or higher), or severe arrhythmia
- Unstable systemic diseases including severe liver, kidney, or metabolic diseases requiring treatment
- Active or uncontrolled infections requiring systemic treatment within 7 days before screening
- Pregnant or breastfeeding women, or planning pregnancy within 2 years after treatment (for female participants or their partners)
- Receiving systemic steroid treatment within 7 days before screening or requiring long-term systemic steroids during treatment (except local or inhaled use)
- Participation in other clinical studies within 1 month before screening
- Evidence of central nervous system invasion by leukemia
- Having graft-versus-host disease or requiring immunosuppressive treatment
- History of epilepsy or other central nervous system disorders
- Primary immunodeficiency diseases
- Unsuitable for CAR-T cell construction as judged by researchers
- Any other condition deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
H
Heng Mei
CONTACT
C
Chenggong Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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