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CAR T-cell Therapy
Cell Therapies for Acute Myeloid Leukemia
Phase 1
Recruiting
Research Sponsored by Arcellx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trialwill assess a new form of therapy for AML and MDS, to determine its safety and effectiveness.
Who is the study for?
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.
What is being tested?
The trial is testing ARC-T cells and SPRX002 to see if they're safe and effective for patients whose AML or MDS hasn't responded to previous treatments. It's an early-phase study which means it's one of the first times these therapies are being tested in humans.
What are the potential side effects?
Potential side effects may include reactions related to the immune system attacking normal cells while targeting cancer cells, infusion-related symptoms like fever or chills during treatment administration, and typical chemotherapy-associated effects such as fatigue, nausea, and increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs) and establish recommended Phase II dose (RP2D)
Secondary study objectives
Anti-Tumor Activity
Pharmacokinetics (PK)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T Cell (ARC-T Cells)Experimental Treatment2 Interventions
Arm 1: Phase 1 Study of monovalent CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T cell (ARC-T Cells) for the Treatment of Patients with Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
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Who is running the clinical trial?
Arcellx, Inc.Lead Sponsor
4 Previous Clinical Trials
630 Total Patients Enrolled
Tim Welliver, MD, PhDStudy ChairArcellx, Inc.
1 Previous Clinical Trials
110 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my brain.I have been treated with experimental gene or CAR-T therapy before.I have been treated with targeted therapy for my cancer.I do not have any active brain disorders.My white blood cell count is very high or my disease is getting worse quickly.I have been diagnosed with acute promyelocytic leukemia.I have been diagnosed with a high-risk form of MDS with more than 10% bone marrow blasts.I am fully active or can carry out light work.My kidney and liver are working well according to my last tests.My cell sample for treatment has been accepted by the lab.I haven't taken any AML/MDS specific treatment recently.I am 18 years old or older.I have cancer other than AML/MDS that needs treatment now.I am not pregnant or breastfeeding.I do not have HIV or HTLV-1.I cannot take cyclophosphamide or fludarabine due to health reasons.I do not have severe illnesses like heart disease, lung problems, bleeding disorders, or autoimmune diseases that are not under control.My AML has returned or didn't respond after 1 or 2 treatments.I have an ongoing infection that hasn't improved with treatment.
Research Study Groups:
This trial has the following groups:- Group 1: CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T Cell (ARC-T Cells)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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