RecruitingPhase 1Phase 2NCT07036250

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.

Sponsor

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

Enrollment

20 participants

Start Date

Jul 3, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukaemia

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.

Eligibility

Min Age: 2 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called U32 in patients with acute myeloid leukemia (AML) — a fast-growing blood cancer — that has come back after treatment or hasn't responded to standard therapy. **You may be eligible if...** - You are between 2 and 65 years old - You have been diagnosed with AML that has relapsed (come back) or is refractory (not responding to treatment) - You are willing to follow all study requirements and sign a consent form **You may NOT be eligible if...** - Your cancer has not been confirmed as AML by current medical guidelines - You have serious organ problems or infections that would make treatment unsafe - You do not meet the specific blood and bone marrow criteria required Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGU32 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.

Locations(1)

The First Affiliated Hospital of Soochow University, Suzhou, JiangSu 215000 Recruiting

Suzhou, China

View Full Details on ClinicalTrials.gov

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NCT07036250

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