NCT06420063 Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML
| NCT ID | NCT06420063 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Essen Biotech |
| Condition | AML |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2025-12-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 85 participants in total. It began in 2024-07-10 with a primary completion date of 2025-12-10.
⚠ 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
This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD33 or CD123 or both sequentially in the treatment of Acute Myelocytic Leukemia.
Eligibility Criteria
Inclusion Criteria: * Subjects with acute myeloid leukemia who voluntarily signed informed consent and met the following criteria: * Age older than 6 months. * Confirmed expression of CLL-1, CD123 and/or CD33 in blast AML by immuno-histochemical staining or flow cytometry. * Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months. * Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL. * Hgb≥80g/L. * No cell separation contraindications. * Abilities to understand and the willingness to provide written informed consent. Exclusion Criteria: * Severe illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. * Active bacterial, fungal or viral infection not controlled by adequate treatment. * Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. * Pregnant or nursing women may not participate. * Use of glucocorticoid for systemic therapy within one week prior to entering the trial. * Patients, in the opinion of investigators, may not be able to comply with the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06420063 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 90 Years, studying AML. 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 NCT06420063 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 NCT06420063 currently recruiting?
Yes, NCT06420063 is actively recruiting participants. Contact the research team at clinical-trials@essen-biotech.com for enrollment information.
Where is the NCT06420063 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06420063 clinical trial?
NCT06420063 is sponsored by Essen Biotech. The trial plans to enroll 85 participants.