Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML

Launched by ESSEN BIOTECH · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for patients with Acute Myeloid Leukemia (AML) using a type of immunotherapy called CAR-T cells. This therapy involves modifying a patient’s own immune cells to target specific markers (CD33 and CD123) found on the cancer cells. The goal is to see if this targeted approach can safely and effectively help patients with AML, particularly those who have not responded to other treatments.

To be considered for this study, patients must be at least 6 months old and have a confirmed diagnosis of AML with specific markers on their cancer cells. Participants should also have good overall health, with certain lab results showing their organs are working well. Those with serious infections or other major health issues will not be eligible. If selected, participants can expect to receive the CAR-T therapy and will be closely monitored for any side effects and how well the treatment is working. It’s important for potential participants to feel comfortable asking questions and discussing their options with their healthcare team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Subjects with acute myeloid leukemia who voluntarily signed informed consent and met the following criteria:
• • 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.
• • Hgb≥80g/L.
• • No cell separation contraindications.
• • Abilities to understand and the willingness to provide written informed consent.
• Exclusion Criteria:
• • 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.
• • Use of glucocorticoid for systemic therapy within one week prior to entering the trial.
• • Patients, in the opinion of investigators, may not be able to comply with the study.