NCT07198867

A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

A Study of A-CAR028 Treatment in Subjects With Relapsed/ Refractory Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients

Detailed description

The study includes the following sequential phases: Screening, Apheresis and A-CAR028 manufacturing, Baseline testing, Lymphodepletion, A-CAR028 infusion, Dose-limiting toxicity observation and Follow-up Visit

Conditions

• Acute Myeloid Leukemia (AML)
• CAR-T Cell Therapy

Interventions

Type	Name	Description
BIOLOGICAL	A-CAR028	A-CAR028 is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD33 and CLL-1 antigens

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-12-30
• Completion: 2027-12-31
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: China