Acute Myeloid Leukemia (AML), CAR-T Cell Therapy
Conditions
Keywords
A-CAR028, Acute Myeloid Leukemia
Brief summary
This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients
Detailed description
The study includes the following sequential phases: Screening, Apheresis and A-CAR028 manufacturing, Baseline testing, Lymphodepletion, A-CAR028 infusion, Dose-limiting toxicity observation and Follow-up Visit
Interventions
BIOLOGICALA-CAR028
A-CAR028 is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD33 and CLL-1 antigens
Sponsors
Shanghai AbelZeta Ltd.
First Affiliated Hospital of Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 75 years old at the time of signing the Informed Consent Form (ICF) * More than 12 weeks of expected survival * ECOG score 0 or 1 * Relapsed or refractory AML * Adequate organ function
Exclusion criteria
* Acute Promyelocytic Leukemia (APL) * Mixed Phenotype Acute Leukemia (MPAL) * Acute Undifferentiated Leukemia (AUL) * Only extramedullary leukemia * Known allergies to the components or excipients of the A-CAR028 cell product * Severe heart diseases, including but not limited to, myocardial infarction, angioplasty or stent implantation within 12 months prior to signing the ICF, unstable angina pectoris, severe arrhythmia, history of severe non-ischemic cardiomyopathy, heart failure * Autologous or allogeneic hematopoietic stem cell transplantation within 3 months prior to signing the ICF * Central nervous system (CNS) involvement or symptoms of CNS involvement (including cranial nerve lesions and extensive lesions or spinal cord compression) * A stroke or seizure occurred within 12 months prior to signing the ICF * Malignancy history within 5 years prior to signing the ICF * Uncontrolled active infection * Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive * Live vaccine injection within 4 weeks prior to signing the ICF * Acute or chronic graft-versus-host disease (GVHD) was present at screening * Inadequate washing time for previous treatment * Previously treated with CAR-T cell products or genetically modified T cell therapies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose limiting toxicities (DLTs) | Throughout the 28 days post A-CAR028 infusion |
| Incidence and severity of Treatment Emergent Adverse Events (TEAEs) | Throughout the 3 months post A-CAR028 infusion |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DOR) | Throughout the 2 years post A-CAR028 infusion |
| Event-free Survival (EFS) | Throughout the 2 years post A-CAR028 infusion |
| Overall Survival (OS) | Throughout the 2 years post A-CAR028 infusion |
| Maximal plasma concentration (Cmax) | Throughout the 2 years post A-CAR028 infusion |
| Incidence and severity of Adverse Events (AEs) | Throughout the 2 years post A-CAR028 infusion |
| Area under the curve within 28 days (AUC0-28d) | Throughout the 2 years post A-CAR028 infusion |
| Time of last measurable observed concentration (Tlast) | Throughout the 2 years post A-CAR028 infusion |
| Changes of CD33/CLL-1 positive cells in bone marrow | Throughout the 2 years post A-CAR028 infusion |
| Time to reach the maximal plasma concentration (Tmax) | Throughout the 2 years post A-CAR028 infusion |
| Overall Response Rate (ORR): including Complete Response (CR), CR with Partial Hematologic Recovery (CRh), CR with Incomplete Hematologic Recovery (CRi), Morphologic Leukemia-free State (MLFS) and Partial Response (PR) | Throughout the 2 years post A-CAR028 infusion |
Countries
China
Contacts
Primary ContactJie Jin, MD
Backup ContactHuafeng Wang, MD
Outcome results
None listed