A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia
This study is testing a new treatment called CD371-YSNVZIL-18 CAR T cells for people with acute myeloid leukemia (AML) that has come back or not responded to previous treatments. CAR T cells are a type of cell therapy where your own immune cells are specially modified to fight cancer. The main goal is to find the highest safe dose of CD371-YSNVZIL-18 CAR T cells that causes the fewest side effects. To join, you must have AML that shows a specific marker called CD371. The study plans to enroll 15 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 15 participants to find the maximum tolerated dose of the treatment.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, maximum tolerated dose, is measured at up to 6 months.
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NCT06017258
A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia
Recruiting
PHASE1Ages 1+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~15 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:CD371-specific/YSNVz/I-18 CAR T cells
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD) of CAR T cells
Measured over up to 6 months
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Mark Geyer, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
History of CD371+ AML
Any disease status is eligible for collection
Expression of CD371 at any level on AML blasts (any method of detection including IHC and/or flow cytometry)
Age/Weight
Pediatrics: ≥ 1 year and ≥ 10kg for collection
Adults: no limit on age/weight for collection
Patients with history of allo-HCT are eligible for collection if:
≥ 100 days post-transplant
no evidence of active GVHD
off any immunosuppressive agents for 30 days prior to collection (physiologic dose of corticosteroids is acceptable)
Relapsed/Refractory CD371+ AML (meeting criteria defined below) for primary refractory AML, late first relapse, and/or advanced disease:
Two or more courses of standard intensive induction chemotherapy (e.g., cytarabine and daunorubicin given as "7+3," MEC, HiDAC, FLAG+idarubicin, etc.);
Two or more cycles of venetoclax in combination with one of the following (azacitidine OR decitabine OR low-dose cytarabine), with or without other agents;
Six or more cycles of azacitidine monotherapy OR four or more courses of decitabine monotherapy
Early first relapse: Patients are eligible from disease perspective in the event of first morphologic relapse or new extramedullary disease less than 12 months after previously having achieved CR, CRh, or CRi following AML-directed therapy
Late first relapse: Patients with first morphologic relapse or new extramedullary disease ≥12 months after previously having achieved CR, CRh, or CRi following AML-directed therapy may respond to intensive re-induction using the initial induction regimen and not eligible from a disease perspective unless the treating investigator feels the patient is unlikely to benefit from repeating the initial induction regimen (for example, relapse occurring 12 months into CR on continuous azacitidine/venetoclax therapy), in which case the rationale for considering enrollment must be clearly documented and risks, benefits, and alternatives discussed with the patient.
Advanced disease: Patients are eligible from disease perspective in the event of relapsed AML refractory to reinduction therapy, relapse following alloHCT, or second or later relapse.
Disease eligibility considerations for all patients: 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 Age: any age is eligible for treatment if eligible for collection
Adequate performance status:
Age ≥ 16 years: ECOG ≤ 1 or Karnosfsky ≥ 60
Age \< 16 years: Lansky ≥ 60
Patients with history of allo-HCT are eligible for treatment if:
≥ 100 days post-transplant
no evidence of active GVHD
off any systemic immunosuppressive agents for 30 days prior to treatment (physiologic dose of corticosteroids is acceptable)
Treating physician considers the patient to be a candidate for second alloHCT
Identification of a suitable donor/source for alloHCT as determined by the treating physician.
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.
Greater than 2 years old: Normal GFR is 100 mL/min/1.73m2.
Infants: GFR must be corrected for body surface area.
Cardiac: LVEF ≥ 50% by MUGA or resting echocardiogram.
Pulmonary: Adequate pulmonary function as assessed by ≥ 92% oxygen saturation on room air by pulse oximetry
Exclusion
Pregnant or lactating women; women of childbearing age, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while receiving study treatment and for at least 12 months after all treatment is finished
Sexually active males, unless they are willing to use a condom during intercourse while receiving study treatment and for at least 12 months after all treatment is finished
Radiographically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥ 5/ul WBC in CSF). Subjects with adequately treated CNS leukemia are eligible.
Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject
Impaired cardiac function (LVEF \< 50%) as assessed by ECHO or MUGA scan
Patients with following cardiac conditions will be excluded:
New York Heart Association (NYHA) stage III or IV congestive heart failure
Myocardial infarction ≤ 6 months prior to enrollment
History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
Positive serologic test results for HIV
Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.
Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR
Patient/parent/LAR unable to give informed consent/
Bridging chemotherapy occurring \< 1 week prior to administration of LDC
Pregnant or lactating women
Radiographically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥ 5/ul WBC in CSF). Subjects with adequately treated CNS leukemia are eligible.
Isolated extramedullary disease
Lack of a suitable donor/source for allogeneic HSCT as determined by the treating physician.
Patients with prior alloHCT are allowed as long as alloHCT occurred ≥100 days prior to date of treatment with CD371-specific/YSNVz/IL-18 CAR T cells and as long as the patient is without ongoing requirement for systemic graft-versus-host therapy
Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject
Impaired cardiac function (LVEF \< 50%) as assessed by ECHO or MUGA scan.
Patients with following cardiac conditions will be excluded:
New York Heart Association (NYHA) stage III or IV congestive heart failure
Myocardial infarction ≤ 6 months prior to enrollment
History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
Positive serologic test results for HIV.
Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.
Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR
Active second malignancy that requires systemic treatments, with the exception of malignancy treated with curative intent and without evidence of disease for \> 2 years before screening
Patient/parent/LAR unable to give informed consent
Any other condition/issue which, in the opinion of the treating physician, would make the patient ineligible for the study; conditions that in the Principal Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
What this trial measures
- Maximum Tolerated Dose (MTD) of CAR T cellsup to 6 months
Determine the Maximum Tolerated Dose/MTD of CAR T cells in participants with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)