OncoMatch/Clinical Trials/NCT06786533
Clinical Study of Anti-FLT3 CAR-T Cells for the Treatment of Relapsed/Refractory AML
Is NCT06786533 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Anti-FLT3 CAR-T cells for relapsed/refractory acute myeloid leukemia (r/r aml).
Treatment: Anti-FLT3 CAR-T cells — This is a phase 1 dose escalation study to determine the safety of anti-FLT3 CAR-T in subjects with R/R AML. The primary objective is to assess safety. Up to 18 evaluable adult and 18 evaluable pediatric subjects will be enrolled. Evaluable subjects are defined as those who have received an infusion of HG-CT-1. Primary clinical objectives: i. Determine the safety of HG-CT-1 based on the proportion of subjects infused with HG-CT-1 who experience a dose limiting toxicity (DLT). Secondary clinical objectives: i. Estimate the efficacy of HG-CT-1 according to standard clinical response criteria for AML. ii. Estimate overall survival of evaluable subjects. iii. Estimate progression-free survival of evaluable subjects. iv. Estimate duration of response in evaluable subjects who achieve a response. Secondary scientific objectives: i. Describe the persistence and trafficking of HG-CT-1. ii. Describe HG-CT-1 bioactivity and its predictors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 expression (detectable in AML blast by flow cytometric analysis)
FLT3 expression must be detectable in AML blast by flow cytometric analysis.
Allowed: FLT3 ITD
Patients with FLT3 ITD must also have failed treatment with a FLT3 inhibitor
Allowed: IDH1 mutation
patients with IDH1 or IDH2 mutations must have failed treatment containing ivosidenib or enasidenib respectively
Allowed: IDH2 mutation
patients with IDH1 or IDH2 mutations must have failed treatment containing ivosidenib or enasidenib respectively
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: intensive chemotherapy (cytarabine, anthracycline) — induction
newly diagnosed AML that after two cycles of intensive chemotherapy has not achieved a complete remission or morphologic leukemia free state by ELN criteria. Intensive chemotherapy must have included either the combination of cytarabine and an anthracycline (7+3 or similar) or combination of venetoclax with a hypomethylating agent.
Must have received: venetoclax with hypomethylating agent (venetoclax) — induction
Intensive chemotherapy must have included either the combination of cytarabine and an anthracycline (7+3 or similar) or combination of venetoclax with a hypomethylating agent.
Must have received: FLT3 inhibitor
Patients with FLT3 ITD must also have failed treatment with a FLT3 inhibitor
Must have received: IDH1 inhibitor (ivosidenib)
patients with IDH1 or IDH2 mutations must have failed treatment containing ivosidenib or enasidenib respectively
Must have received: IDH2 inhibitor (enasidenib)
patients with IDH1 or IDH2 mutations must have failed treatment containing ivosidenib or enasidenib respectively
Lab requirements
Kidney function
Creatinine ≤ 1.6 mg/dl and Creatinine clearance (CrCl) ≥ 60 mL/min
Liver function
ALT/AST ≤ 3 x upper limit of normal unless related to disease; Direct bilirubin < 2.0mg/dl unless subject has Gilbert's syndrome (≤3.0 mg/dL)
Cardiac function
Left ventricular ejection fraction ≥ 45% as confirmed by echocardiogram or MUGA
Satisfactory organ functions: Creatinine ≤ 1.6 mg/dl and Creatinine clearance (CrCl) ≥ 60 mL/min. ALT/AST must be ≤ 3 x upper limit of normal unless related to disease. Direct bilirubin < 2.0mg/dl unless subject has Gilbert's syndrome (≤3.0 mg/dL). Left ventricular ejection fraction ≥ 45% as confirmed by echocardiogram or MUGA. DLCO >45% predicted and O2 Saturation > 90% on room air.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson · Houston, Texas
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