Actively Recruiting
A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-10
40
Participants Needed
7
Research Sites
208 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
T
Takeda
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to test the safety of ADCLEC.syn1 CAR T cells in people with relapsed or refractory AML. The researchers will try to find the highest dose of ADCLEC.syn1 CAR T cells that causes few or mild side effects in participants. Once the researchers find this dose, it will test it in a new group of participants to see if it is effective in treating their relapsed/refractory AML.
CONDITIONS
Official Title
A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of signing consent
- Diagnosis of relapsed or refractory AML
- ECOG performance status of 0 or 1
- Suitable stem cell donor identified in case of need for allogeneic stem cell transplant
- Adequate organ function: serum creatinine less than 2.0 mg/100 mL, total bilirubin less than 2.0 mg/100 mL (except benign causes), AST and/or ALT no more than 5 times the upper limit of normal (unless due to leukemia involvement)
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Active or symptomatic central nervous system (CNS) disease or CNS 3 disease
- Oxygen saturation below 90% on room air
- Treatment with clofarabine or cladribine within 3 months before leukapheresis
- Use of therapeutic corticosteroids above specified doses shortly before treatment
- Bridging chemotherapy including venetoclax within 1 week prior to conditioning chemotherapy
- Significant cardiovascular disease or unstable heart conditions
- Uncontrolled infections requiring new oxygen support or ongoing fever
- Positive HIV test
- Active hepatitis B or C infection
- Active second cancer requiring systemic treatment
- Live vaccine within 4 weeks before leukapheresis
- Pregnant or breastfeeding
- Any condition judged by the investigator to make the patient ineligible
AI-Screening
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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 Commack - Suffolk (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
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
J
Jae Park, MD
CONTACT
M
Mark Geyer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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