Tests CAR-T cell therapy in adults with returning or resistant acute myeloid leukemia
Tests anti Tim-3/CD123 CAR-T cells in adults with relapsed or refractory leukemia.
Plain-language title generated from the registry record
Registry title: Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)
Key facts
- Where
- Xuzhou, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with acute myeloid leukemia that came back or did not respond to earlier treatment. It tests anti Tim-3/CD123 CAR-T cell therapy.
- Age
- 18-70 years
- Sex
- Men and women can join.
- Disease stage
- Relapsed or refractory acute myeloid leukemia (AML), either de novo or secondary.
- Earlier treatment
- Must have recovered from the side effects of previous treatment.
Main reasons for not taking part
- Acute promyelocytic leukemia
- History of organ transplant surgery
- Positive HBsAg, HIV or syphilis antibody tests
- Uncontrolled infection
- Active autoimmune or inflammatory nervous system disease or a CNS disorder
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06125652, who can take part
Where in China
- Kailin XuXuzhou, ChinaContact: Kailin Xu, M.D., Ph.D.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Xuzhou Medical University
- Trial code
- NCT06125652
- Record updated
- 9 November 2023
- Original description
To evaluate the safety and efficacy of anti Tim3/CD123 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.Read full original descriptionShow less
Application of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)
To evaluate the safety and efficacy of anti Tim3/CD123 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.
Inclusion: All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities; At the age of 18-70 years old; Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML); The patient has recovered from the toxicity of previous treatment; ECOG score ≤ 2 and expected survival period is not less than 3 months; Adequate organ function defined as:AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL/min; Hemoglobin ≥60g/L ; Indoor oxygen saturation ≥92%; LVEF≥45%; Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test; From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception.
Exclusion: History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment; Required systemic application of immunosuppressive or other drugs; Auto-SCT within the 3 months before enrollment; Live vaccine received within the ≤ 4 weeks before enrollment; History of major surgical operations four weeks before enrollment; History or presence of a CNS disorder; HBsAg is positive; HCV #HIV or Syphilis antibody are positive, CMV-DNA in peripheral blood is more than≥500 copies /mL; History of severe hypersensitivity reaction; History of organ transplant surgery; Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)); Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) ; Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management; Persons with serious mental illness; History of alcoholism or substance abuse; Diagnosis of acute promyelocytic leukemia; Was identified by the investigators as unsuitable to participate in the study.