Actively Recruiting
Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)
Led by Xuzhou Medical University · Updated on 2023-11-09
20
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of anti Tim3/CD123 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.
CONDITIONS
Official Title
Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before starting study procedures
- Age between 18 and 70 years old
- Diagnosed with relapsed or refractory de novo or secondary acute myeloid leukemia
- Recovered from previous treatment toxicity
- ECOG score of 2 or less and expected survival of at least 3 months
- Adequate organ function including liver enzymes, bilirubin, kidney function, hemoglobin, oxygen saturation, and heart function
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception from study drug use until 2 years after treatment for males and females of childbearing potential
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- History or current central nervous system disorders
- Positive tests for hepatitis B surface antigen, hepatitis C virus, HIV, syphilis, or high CMV-DNA in blood
- History of severe allergic reactions
- Recent significant heart disease or interventions within 12 months
- History of organ transplant surgery
- Need for systemic immunosuppressive or other drugs
- Autologous stem cell transplant within 3 months before enrollment
- Active autoimmune or inflammatory nervous system diseases or cerebrovascular diseases
- Urgent need for therapy due to oncologic emergencies like leukostasis or tumor lysis syndrome
- Presence or suspicion of uncontrolled infections requiring treatment
- Live vaccine within 4 weeks before enrollment
- Serious mental illness
- Major surgery within 4 weeks before enrollment
- History of alcoholism or substance abuse
- Deemed unsuitable by investigators for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kailin Xu
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
Research Team
K
Kailin Xu, MD.,PD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here