Actively Recruiting
Application 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of anti Tim-3/CD123 CAR-T cell therapy for treating patients with relapsed or refractory acute myeloid leukemia (AML). The study focuses on improving the targeting of leukemia stem cells (LSCs) by using both Tim-3 and CD123 markers. Tim-3 has higher specificity for LSCs compared to CD123 alone, potentially reducing harmful effects on normal blood stem cells and decreasing complications such as infections and organ damage. Participants will receive a prespecified dose of their own engineered CAR-T cells that target both Tim-3 and CD123. This therapy is designed to better recognize and attack leukemia cells while sparing normal cells. The study includes early and later phase evaluations to assess dose safety and treatment response over time. During the study, participants will be closely monitored for side effects and treatment outcomes. The primary measure is dose-limiting toxicity within 28 days after the CAR-T cell infusion. Secondary outcomes include response rates, event-free survival, and overall survival assessed at 3, 6, 12, 18, and 24 months. Participants will undergo regular clinical assessments and laboratory tests to track their health and response to the therapy throughout the study period.
CONDITIONS
Brief 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 any study procedures
- Age between 18 and 70 years
- Diagnosed with relapsed or refractory de novo or secondary acute myeloid leukemia
- Recovery from toxicity of previous treatments
- ECOG performance status of 2 or less and expected survival of at least 3 months
- Adequate organ function including specific lab value limits for liver, kidney, 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 post-treatment for males and females of childbearing potential
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- History or presence of central nervous system disorders
- Positive tests for HBsAg, HCV, HIV, syphilis antibodies, or high CMV-DNA levels
- History of severe allergic reactions
- Significant cardiac disease or events within 12 months before enrollment
- 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
- Requirement for urgent therapy due to oncologic emergencies
- Uncontrolled infections requiring treatment
- Receipt of live vaccine within 4 weeks before enrollment
- Serious mental illness
- Major surgery within 4 weeks before enrollment
- History of alcoholism or substance abuse
- Investigator-determined unsuitability for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days after CAR-T cells infusion
Participants receive a prespecified dose of autologous anti Tim-3/CD123 CAR-T cells to treat relapsed and refractory acute myeloid leukemia.
1 infusion visit and multiple monitoring visits during 28 days post-infusion
Duration - Up to 24 months
Participants are monitored for treatment response and safety outcomes including overall response rate, event-free survival, and overall survival.
Scheduled visits at 3, 6, 12, 18, and 24 months post-treatment
Trial Site Locations
Total: 1 location
1
Kailin Xu
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
Research Team
K
Kailin Xu, MD.,PD.
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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