OncoMatch/Clinical Trials/NCT06760260
Evaluation of the Safety and Efficacy of Human CI-135 (FLT3) Targeted CAR-T Cells Injection for Subjects with Relapsed/Refractory Acute Myeloid Leukemia
Is NCT06760260 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Human Derived anti-CI135 CAR-T for acute myeloid leukemia (aml).
Treatment: Human Derived anti-CI135 CAR-T — This study is a single-arm, open-label, dose-escalating trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of anti human CI-135 (FLT3) CAR-T Injection , and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory Acute Myeloid Leukemia.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 mutation
Positive for FLT3 mutation confirmed by leukemia cell genetic testing
Required: FLT3 overexpression (≥35%)
FLT3 expression ≥35%
Performance status
ECOG 1–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard induction therapy
AML patients who have not achieved complete remission (CR) after at least three cycles of standard induction therapy
Must have received: tyrosine kinase inhibitor
For patients meeting conditions a), b), or c) with FLT3 mutations, they must have undergone at least one treatment with a tyrosine kinase inhibitor (TKI) without achieving complete remission or have relapsed after achieving complete remission, except for those who cannot tolerate TKI therapy or have contraindications to TKI treatment.
Cannot have received: CAR-T cell therapy
Previously treated with CAR-T cells or other genetically modified cellular therapies
Lab requirements
Kidney function
Glomerular filtration rate (GFR) ≥60 ml/min/1.73 m² or serum creatinine ≤2 times the upper limit of normal (ULN)
Liver function
Serum AST and ALT ≤3 times of ULN, and total bilirubin ≤1.5 times the ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50%, with no pericardial effusion observed on ultrasound, and no clinically significant electrocardiographic abnormalities
Liver, kidney, heart, and lung functions meeting the following criteria: 1. Glomerular filtration rate (GFR) ≥60 ml/min/1.73 m² or serum creatinine ≤2 times the upper limit of normal (ULN); 2. Serum AST and ALT ≤3 times of ULN, and total bilirubin ≤1.5 times the ULN; 3. Oxygen saturation > 92%; 4. Left ventricular ejection fraction (LVEF) ≥50%, with no pericardial effusion observed on ultrasound, and no clinically significant electrocardiographic abnormalities.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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