Multi-CAR T Cell Therapy for Acute Myeloid Leukemia
Recruiting now · Phase 1/Phase 2
Conditions studied: Acute Myeloid Leukemia
In brief
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multi-CAR T cell therapy targeting different AML surface antigens in patients with relapsed or refractory acute myeloid leukemia (AML). Another goal of the study is to learn more about the function of the multi-CAR T cells and their persistency in the patients.
Key facts
- Study ID
- NCT03222674
- Run by
- Shenzhen Geno-Immune Medical Institute
- People needed
- 10
- Starts
- 2025-07-15
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-06-23
Who can join
Age: 2 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age older than 2 years.
- CD33, CD38, CD56, CD123, MucI, and CLL1 expression can be identified in the malignant cells by immuno-histochemical staining or flow cytometry.
- Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 2 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.
You may not qualify if…
- Sever 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 or hepatitis B virus (HBV) infection.
- Pregnant or nursing women may not participate.
- History of glucocorticoid for systemic therapy within the week prior to entering the test.
- Previously treatment with any gene therapy products.
- Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Where it is running
- Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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