← Back to Search

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 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

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

Find a Location

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

Media Library

ARC-T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05457010 — Phase 1
Myelodysplastic Syndrome Research Study Groups: CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T Cell (ARC-T Cells)
Myelodysplastic Syndrome Clinical Trial 2023: ARC-T Cells Highlights & Side Effects. Trial Name: NCT05457010 — Phase 1
ARC-T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05457010 — Phase 1
~7 spots leftby Sep 2025