NCT06125652 Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)
| NCT ID | NCT06125652 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Xuzhou Medical University |
| Condition | Acute Myeloid Leukemia Refractory |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-11-04 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-11-04 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the safety and efficacy of anti Tim3/CD123 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.
Eligibility Criteria
Inclusion Criteria: 1. All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities; 2. At the age of 18-70 years old; 3. Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML); 4. The patient has recovered from the toxicity of previous treatment; 5. ECOG score ≤ 2 and expected survival period is not less than 3 months; 6. 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%; 7. Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test; 8. 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 Criteria: 1. Diagnosis of acute promyelocytic leukemia; 2. History or presence of a CNS disorder; 3. HBsAg is positive; HCV #HIV or Syphilis antibody are positive, CMV-DNA in peripheral blood is more than≥500 copies /mL; 4. History of severe hypersensitivity reaction; 5. 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; 6. History of organ transplant surgery; 7. Required systemic application of immunosuppressive or other drugs; 8. Auto-SCT within the 3 months before enrollment; 9. 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)); 10. Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) ; 11. Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management; 12. Live vaccine received within the ≤ 4 weeks before enrollment; 13. Persons with serious mental illness; 14. History of major surgical operations four weeks before enrollment; 15. History of alcoholism or substance abuse; 16. Was identified by the investigators as unsuitable to participate in the study.
Contact & Investigator
Kailin Xu, MD.,PD.
STUDY CHAIR
The Affiliated Hospital oh Xuzhou Medical University
Frequently Asked Questions
Who can join the NCT06125652 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Acute Myeloid Leukemia Refractory. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06125652 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06125652 currently recruiting?
Yes, NCT06125652 is actively recruiting participants. Contact the research team at lihmd@163.com for enrollment information.
Where is the NCT06125652 trial being conducted?
This trial is being conducted at Xuzhou, China.
Who is sponsoring the NCT06125652 clinical trial?
NCT06125652 is sponsored by Xuzhou Medical University. The principal investigator is Kailin Xu, MD.,PD. at The Affiliated Hospital oh Xuzhou Medical University. The trial plans to enroll 20 participants.
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