Cell Therapies for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and early effectiveness of two new treatments, ARC-T cells (a type of cell therapy) and SPRX002 (an experimental treatment), for individuals with relapsed or hard-to-treat acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). These conditions prevent the bone marrow from producing healthy blood cells. The trial seeks participants with AML or MDS that hasn't responded to standard treatments or who have undergone previous bone marrow transplants. Participants should be ready for long-term follow-up and have a potential donor available if a new transplant becomes necessary. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive these innovative therapies.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that CAR-T cell therapies, such as ARC-T cells, can help the immune system combat certain cancers. Other studies on similar CAR-T therapies suggest they can be safe, but they might also cause side effects like tiredness and fever.
For SPRX002, limited safety information exists because the research is still in its early stages. Since this study is in Phase 1, the main goal is to determine if the treatment is safe for people. This phase is crucial for understanding how well people can tolerate the treatment before conducting further tests.
Although the safety of ARC-T cells and SPRX002 is not yet fully understood, this study will provide important information on how patients respond to these treatments.12345Why are researchers excited about this trial's treatments?
Unlike the standard chemotherapy treatments for Acute Myeloid Leukemia (AML), which primarily aim to kill rapidly dividing cells, ARC-T Cells and SPRX002 introduce a groundbreaking approach by targeting specific elements of the cancer cells. ARC-T Cells are universally modified T cells designed to recognize and attack cancer cells, while SPRX002 serves as a CD123-specific adapter that guides these T cells directly to the AML cells. This combination allows for a highly targeted attack on the leukemia cells, potentially minimizing damage to healthy cells and reducing side effects. Researchers are excited about these treatments because they represent a shift towards precision medicine, offering hope for more effective and personalized therapies for patients with relapsed or refractory AML.
What evidence suggests that this trial's treatments could be effective for acute myeloid leukemia?
Research has shown that T-cell therapies, such as ARC-T cells, hold promise for treating acute myeloid leukemia (AML). These treatments have reprogrammed the body's immune cells to attack cancer in previous AML patients. CAR-T cell therapy, used in ARC-T cells, has successfully targeted cancer cells, though challenges remain in overcoming the cancer's defenses.
In this trial, participants will receive a combination of ARC-T Cells and SPRX002. SPRX002 specifically targets the CD123 marker found on leukemia cells. Studies over the past 20 years have identified CD123 as a strong target for treating blood cancers, including AML. These therapies aim to precisely attack leukemia cells while sparing healthy ones, potentially leading to better outcomes for patients whose AML has returned or is resistant to other treatments.13678Who Is on the Research Team?
Tim Welliver, MD, PhD
Principal Investigator
Arcellx, Inc.
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- ARC-T Cells
- SPRX002
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arcellx, Inc.
Lead Sponsor