NCT07036250

Clinical Study of U32 in Patients With Acute Myeloid Leukemia

A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U32 Injection in Patients With Acute Myeloid Leukemia.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Industry
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U32 injection in patients with acute myeloid leukemia.

Detailed description

The primary objective of this study is to evaluate the safety and tolerability of U32 in the treatment of acute myeloid leukemia and to determine the safe and effective dosage.

Conditions

• Acute Myeloid Leukaemia

Interventions

Type	Name	Description
DRUG	U32 CAR-T	Lymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days.

Timeline

• Start date: 2025-07-03
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2025-06-25
• Last updated: 2025-06-25

Locations

1 site across 1 country: China