At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older at informed consent
- ✓Relapsed or refractory AML with specific prior treatment history
- ✓Refractory AML defined as failure to achieve CR/CRh/CRi after standard induction, HMA, or venetoclax combinations or 4 cycles HMA monotherapy
- ✓Relapsed AML defined as ≥5% blasts in bone marrow or peripheral blood after prior CR/CRh/CRi
- ✕Diagnosis of acute promyelocytic leukemia (APL)
- ✕Radiologically-detected or symptomatic CNS disease or CNS 3 disease (≥5/µL WBCs in CSF), unless adequately treated
- ✕Oxygen saturation <90% on room air
- ✕Clofarabine or cladribine within 3 months prior to leukapheresis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Study of ADCLEC.syn1 CAR T Cells in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia
In Brief
A Phase 1 clinical trial evaluating ADCLEC.syn1 CAR T cells and Conditioning chemotherapy for Acute Myeloid Leukemia. Currently recruiting, targeting 40 participants across 7 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
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.
Fludarabine 30 mg/m2 daily for 3 days and cyclophosphamide 500 mg/m2 daily for 3 days.