NCT05748197

A Phase I Study of ADCLEC.syn1 CAR T Cells in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia

Study Summary

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.

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Interventions

ADCLEC.syn1 CAR T cellsBIOLOGICAL
There are 4 planned flat-dose levels: 25 × 10\^6, 75 × 10\^6 , 225 × 10\^6 , and 450 × 10\^6 CAR T cells and 1 de-escalation dose: 10 × 10\^6 CAR T cells.
Conditioning chemotherapyDRUG
Fludarabine 30 mg/m2 daily for 3 days and cyclophosphamide 500 mg/m2 daily for 3 days.

Study Locations

FacilityCityStateCountry
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew JerseyUnited States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew JerseyUnited States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew JerseyUnited States
Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)CommackNew YorkUnited States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew YorkUnited States
Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew YorkUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026