CD371-targeted CAR T cells secreting interleukin-18 exhibit robust expansion and clear refractory acute myeloid leukemia.
Mark B Geyer, Susan DeWolf, Xiaoli Mi...
https://pubmed.ncbi.nlm.nih.gov/40864984Actively Recruiting
Phase 1
Age: 1Year +
All Genders
ID06017258
Phase I Trial of CLEc12a (CD371) Targeted ArmoRed Immune Effector Cells in Patients With Relapsed/Refractory Acute Myeloid Leukemia (CLEAR-AML)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-19
15
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and appropriate dosing of CD371-YSNVZ-IL18 CAR T cells in people with relapsed or refractory acute myeloid leukemia (AML). This phase 1 trial aims to find the highest dose of these CAR T cells that causes few or mild side effects. The study focuses on participants with CD371-positive AML who have experienced treatment failure or relapse and may have had previous stem cell transplants. Participants receive escalating doses of CD371-specific/YSNVz/IL-18 CAR T cells combined with lymphodepleting chemotherapy to determine the maximum tolerated dose. There is also a lower dose level available for dose reduction if severe side effects occur. The study includes multiple dose levels and plans to monitor patients closely throughout the treatment. During the trial, participants will undergo various assessments including monitoring of side effects, organ function tests, and disease status evaluation. Researchers will measure the maximum tolerated dose of CAR T cells over up to six months. Participants with previous transplant history must meet specific conditions before treatment. The total participation timeframe and safety monitoring are integral parts of the study process.
CONDITIONS
Brief Title
A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia
Who Can Participate
Age: 1Year +
All Genders
Eligibility Criteria
You may qualify if you...
- History of CD371-positive acute myeloid leukemia
- Expression of CD371 on AML blasts by any detection method
- Age at least 1 year and weight at least 10 kg for T cell collection
- Adults have no age/weight limit for collection
- Patients with prior allogeneic stem cell transplant must be at least 100 days post-transplant, have no active graft-versus-host disease, and be off immunosuppressive agents for 30 days
- Relapsed or refractory CD371-positive AML with specific disease criteria including primary refractory AML, early or late first relapse, or advanced disease
- Adequate performance status (ECOG 0-1 or Lansky score ≥60 depending on age)
- Adequate organ function including liver, kidney, heart, and lung function
- Identification of suitable donor/source for allogeneic stem cell transplant as determined by physician
You will not qualify if you...
- Pregnant or lactating women; women of childbearing potential must use effective contraception during and for 12 months after treatment
- Sexually active males must use condoms during and for 12 months after treatment
- Radiographically detected or symptomatic central nervous system leukemia with ≥5 white blood cells/µL in cerebrospinal fluid, except adequately treated CNS leukemia
- Uncontrolled infections, psychiatric illness, or social situations limiting study compliance
- Impaired cardiac function with LVEF below 50% or severe heart conditions
- Positive tests for HIV, hepatitis B, or hepatitis C infections
- Bridging chemotherapy less than 1 week prior to lymphodepleting chemotherapy (except hydroxyurea within specified timeframes)
- Isolated extramedullary disease
- Lack of suitable donor/source for allogeneic stem cell transplant
- Active second malignancy requiring systemic treatment except those treated curatively with no disease for over 2 years
- Inability to provide informed consent
- Any other condition that the physician believes would interfere with study participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 months
Participants receive escalating doses of CD371-specific CAR T cells with lymphodepleting chemotherapy to establish the maximum tolerated dose. Dose adjustments may occur based on toxicity.
Multiple visits during dosing and monitoring
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States, 11553
Actively Recruiting
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Research Team
M
Mark Geyer, MD
J
Jae Park, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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