OncoMatch/Clinical Trials/NCT06017258
A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia
Official title: Phase I Trial of CLEc12a (CD371) Targeted ArmoRed Immune Effector Cells in Patients With Relapsed/Refractory Acute Myeloid Leukemia (CLEAR-AML)
Is NCT06017258 recruiting? Yes, currently enrolling (Oct 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
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CLEC12A expression (any)
Expression of CD371 at any level on AML blasts (any method of detection including IHC and/or flow cytometry)
Demographics
Lab requirements
Kidney function
Serum creatinine < 2.0 mg/100 ml (> 18 years) or ≤ 2.5 x ULN for age; if outside normal range, CrCl > 40 mL/min/1.73m2 or GFR > 40% of predicted normal for age
Liver function
Serum total bilirubin ≤ 1.5 mg/dL unless benign congenital hyperbilirubinemia or disease related; ALT and AST < 3x ULN unless 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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06017258 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require CLEC12A?
Yes, CLEC12A expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages