Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-90
SponsorEssen Biotech
About this trial
This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD33 or CD123 or both sequentially in the treatment of Acute Myelocytic Leukemia.
Eligibility criteria
Qualifiers
Age older than 6 months.
Confirmed expression of CLL-1, CD123 and/or CD33 in blast AML by immuno-histochemical staining or flow cytometry.
Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 3 months.
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL.
Disqualifiers
Severe illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
Active bacterial, fungal or viral infection not controlled by adequate treatment.
Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Pregnant or nursing women may not participate.
Trial design
Treatments tested in this trial
- CD123/CD33 CART
Treatment groups
85 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov