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New treatment option for Acute Myeloid Leukemia (AML)
Official title A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT07198867
What this study is testing
What is A-CAR028?
A-CAR028 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia (aml).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.