Cell Therapies for Acute Myeloid Leukemia
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should not use any anti-AML/MDS directed chemotherapy or targeted therapy (except hydroxyurea) within 14 days or 5 half-lives before leukapheresis, and no monoclonal antibodies within 28 days before leukapheresis.
What data supports the effectiveness of the treatment ARC-T Cells for Acute Myeloid Leukemia?
Research indicates that CD123-targeted therapies, like ARC-T Cells, show promise in treating acute myeloid leukemia (AML) due to their ability to target specific antigens on leukemia cells. However, challenges remain due to the overlap of these antigens with normal cells, which can lead to side effects.12345
Is the cell therapy for acute myeloid leukemia generally safe in humans?
Research on similar cell therapies for acute myeloid leukemia shows mixed safety results. Some studies indicate that certain therapies can target leukemia cells without harming normal cells, while others suggest potential risks of damaging normal blood-forming cells, which could lead to serious side effects.14678
How is the ARC-T Cells, SPRX002 treatment different from other treatments for acute myeloid leukemia?
The ARC-T Cells, SPRX002 treatment is unique because it uses engineered T cells that specifically target the CD123 antigen on leukemia cells, potentially reducing the risk of attacking normal cells. This approach aims to improve the precision and effectiveness of treatment compared to traditional therapies.1891011
What is the purpose of this trial?
The purpose of this study is to evaluate the safety and preliminary activity of ARC-T cells and SPRX002 in participants with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS)
Research Team
Tim Welliver, MD, PhD
Principal Investigator
Arcellx, Inc.
Eligibility Criteria
Adults with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS), who have tried certain treatments without success, can join. They must be in good general health with proper organ function and not pregnant. People are excluded if they've had recent heart issues, other active cancers needing treatment, severe infections, autoimmune diseases, or a history of certain blood clots.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Enrollment
Participants are enrolled into the study after meeting eligibility criteria
Pretreatment with Lymphodepletion Chemotherapy
Participants receive lymphodepletion chemotherapy prior to cell therapy
Treatment
Participants receive a single infusion of SPRX002 and ARC-T cells followed by regular administration of SPRX002
Treatment Extension
Continued administration of SPRX002 to assess long-term efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Safety Follow-up
Long-term safety data collection for up to 15 years as per health authority guidelines
Treatment Details
Interventions
- ARC-T Cells
- SPRX002
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arcellx, Inc.
Lead Sponsor