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A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia

NCT05748197 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-10

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

ADCLEC.syn1 CAR T cells

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.

DRUG

Conditioning chemotherapy

Fludarabine 30 mg/m2 daily for 3 days and cyclophosphamide 500 mg/m2 daily for 3 days.

Sponsors & Collaborators

Principal Investigators

  • Jae Park, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-18
Primary Completion
2028-04-18
Completion
2028-04-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05748197 on ClinicalTrials.gov