Acute Myeloid Leukemia Clinical Trial
— BAH244Official title:
Sequential CAR-T Cell Infusion Targeting CD33 and CD123 for Refractory/Relapsed Acute Myeloid Leukaemia
Verified date | May 2024 |
Source | Essen Biotech |
Contact | JAMAL ALKHAYER |
Phone | +97333799773 |
ceo[@]essen-biotech.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 85 |
Est. completion date | December 28, 2026 |
Est. primary completion date | December 10, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | District one hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Essen Biotech |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and severity of dose-limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD5/CD7 chimeric antigen receptor (CAR) T cells | Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at three dose levels until the maximum tolerated dose (MTD) is determined. | 28 days | |
Secondary | Rate of successful manufacture and expansion of the CD33/123 chimeric antigen receptor (CAR) T cells | satisfy the targeted dose level and meet the required release specifications outlined in the Certificate of Analysis (COA) | 10-14 days |
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