OncoMatch/Clinical Trials/NCT06017258
A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia
Is NCT06017258 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CD371-specific/YSNVz/I-18 CAR T cells for refractory acute myeloid leukemia.
Treatment: CD371-specific/YSNVz/I-18 CAR T cells — The purpose of this study is to find out whether CD371-YSNVZ-IL18 CAR T cells are safe, and to look for the highest dose of CD371-YSNVZ-IL18 CAR T cells that cause few or mild side effects in participants.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CD371 overexpression (any level)
Expression of CD371 at any level on AML blasts (any method of detection including IHC and/or flow cytometry)
Allowed: IDH1 mutation
Patients with relapsed or refractory AML with susceptible mutations for which there is an FDA approved therapy (for example, IDH1 mutation, ivosidenib; IDH2 mutation, enasidenib; FLT3-ITD/TKD, gilteritinib) are not eligible from a disease perspective unless they meet one or more of the below criteria: Failure to achieve CR, CRh, or CRi following therapy with one or more targeted therapies for relapsed or refractory AML directed to the actionable mutation(s); Intolerance of one or more targeted therapies for relapsed or refractory AML directed to the actionable mutation(s); Treating investigator feels the patient would be unlikely to benefit from FDA-approved targeted therapy based on disease characteristics, in which case the rationale for considering enrollment must be clearly documented and risks, benefits, and alternatives discussed with the patient
Allowed: IDH2 mutation
Patients with relapsed or refractory AML with susceptible mutations for which there is an FDA approved therapy (for example, IDH1 mutation, ivosidenib; IDH2 mutation, enasidenib; FLT3-ITD/TKD, gilteritinib) are not eligible from a disease perspective unless they meet one or more of the below criteria: Failure to achieve CR, CRh, or CRi following therapy with one or more targeted therapies for relapsed or refractory AML directed to the actionable mutation(s); Intolerance of one or more targeted therapies for relapsed or refractory AML directed to the actionable mutation(s); Treating investigator feels the patient would be unlikely to benefit from FDA-approved targeted therapy based on disease characteristics, in which case the rationale for considering enrollment must be clearly documented and risks, benefits, and alternatives discussed with the patient
Allowed: FLT3 ITD
FLT3-ITD, gilteritinib
Allowed: FLT3 TKD
FLT3-TKD, gilteritinib
Lab requirements
Kidney function
serum creatinine < 2.0 mg/100 ml (> 18 years) or ≤ 2.5 x institutional upper limit of normal (ULN) for age; If serum creatinine is outside the normal range, then CrCl > 40 mL/min/1.73m2 (calculated or estimated) or GFR (mL/min/1.73m2) > 40% of predicted normal for age.
Liver function
Serum total bilirubin ≤ 1.5 mg/dL, unless benign congenital hyperbilirubinemia or unless thought to be disease related. ALT and AST < 3 times the upper limit of normal unless thought to be disease-related.
Cardiac function
LVEF ≥ 50% by MUGA or resting echocardiogram.
Adequate organ function is required, defined as follows: Hepatic: Serum total bilirubin ≤ 1.5 mg/dL, unless benign congenital hyperbilirubinemia or unless thought to be disease related. Hepatic: ALT and AST < 3 times the upper limit of normal unless thought to be disease-related. Renal: serum creatinine < 2.0 mg/100 ml (> 18 years) or ≤ 2.5 x institutional upper limit of normal (ULN) for age. If serum creatinine is outside the normal range, then CrCl > 40 mL/min/1.73m2 (calculated or estimated) or GFR (mL/min/1.73m2) > 40% of predicted normal for age. Cardiac: LVEF ≥ 50% by MUGA or resting echocardiogram. Pulmonary: Adequate pulmonary function as assessed by ≥ 92% oxygen saturation on room air by pulse oximetry
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited protocol activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) · Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York
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