CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T Cell (ARC-T Cells) for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Myeloid Leukemia+1 MoreARC-T Cells - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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)

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 24 months

24 months
Adverse Events and Dose-Limiting Toxicities
Anti-Tumor Activity
Anti-tumor activity
Incidence of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs) and establish recommended Phase II dose (RP2D)
Pharmacokinetics (PK)
Pharmacokinetics (PK) profile

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T Cell (ARC-T Cells)
1 of 1

Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T Cell (ARC-T Cells) · No Placebo Group · Phase 1

CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T Cell (ARC-T Cells)Experimental Group · 3 Interventions: ARC-T Cells, SPRX002, ARC-T · Intervention Types: Biological, Biological, Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Arcellx, Inc.Lead Sponsor
2 Previous Clinical Trials
175 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be at least 18 years old.
You have been treated for AML with one or more standard treatments and have relapsed or refractory disease after 1 or 2 lines of therapy.
You have a performance status of 0 or 1.
You have adequate renal and hepatic function.
Creatinine clearance ≥50 ml/min (Cockcroft-Gault or 24-hour urine collection in cases in which Cockroft-Gault is unreliable or if preferred by physician) and not on dialysis.