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Clinical Study of U32 in Patients With Acute Myeloid Leukemia

NCT07036250 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-25

No results posted yet for this study

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.

Conditions

  • Acute Myeloid Leukaemia

Interventions

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.

Sponsors & Collaborators

  • Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Xiaowen Tang, Ph.D. · The First Affiliated Hospital of Soochow University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-03
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07036250 on ClinicalTrials.gov