NCT05995041 Universal CAR-T Cells Targeting AML
| NCT ID | NCT05995041 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shenzhen Geno-Immune Medical Institute |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-12-31 |
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 30 participants in total. It began in 2026-06-01 with a primary completion date of 2029-12-31.
⚠ 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
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T-cell products targeting CLL-1, CD33, CD38 and CD123 in patients with relapsed and refractory AML. The study also aims to learn more about the function of the universal CAR T cells and their persistency in AML patients.
Eligibility Criteria
Inclusion Criteria: 1. Age older than 6 months. 2. Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by immuno-histochemical staining or flow cytometry. 3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months. 4. 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. 5. Hgb≥80g/L. 6. No cell separation contraindications. 7. Abilities to understand and the willingness to provide written informed consent. Exclusion Criteria: 1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. 2. Active bacterial, fungal or viral infection not controlled by adequate treatment. 3. Known HIV or active hepatitis C virus (HCV) infection. 4. Pregnant or nursing women may not participate. 5. Use of glucocorticoid for systemic therapy within one week prior to entering the trial. 6. Previous treatment with any gene therapy products. 7. The bone marrow AML burden (MRD) is above 50%. 8. Patients, in the opinion of investigators, may not be able to comply with the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05995041 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 75 Years, studying Acute Myeloid Leukemia. 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 NCT05995041 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 NCT05995041 currently recruiting?
Yes, NCT05995041 is actively recruiting participants. Contact the research team at c@szgimi.org for enrollment information.
Where is the NCT05995041 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT05995041 clinical trial?
NCT05995041 is sponsored by Shenzhen Geno-Immune Medical Institute. The trial plans to enroll 30 participants.
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