RecruitingPhase 1Phase 2NCT06118788

Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

A Single-arm, Dose-escalation and Dose-expansion Phase I Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia


Sponsor

Guangzhou Bio-gene Technology Co., Ltd

Enrollment

24 participants

Start Date

Mar 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, single-dose dose-escalation and dose-expansion study.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell therapy called BG1805 for people with acute myeloid leukemia (AML) — a cancer of the blood — that has come back or stopped responding to treatment. Researchers want to find out if this treatment is safe and effective. **You may be eligible if...** - You are 18–70 years old - You have been diagnosed with relapsed or refractory AML that has returned after remission or did not respond to at least 2 standard treatments - Your leukemia cells test positive for a specific protein called CLL-1 (≥50%) - You are in generally good health (able to carry out normal activity) and expected to live more than 3 months - Your liver, kidneys, and heart are functioning adequately **You may NOT be eligible if...** - You have a type of AML called acute promyelocytic leukemia - You have another active cancer diagnosed in the last 3 years - You have cancer that has spread to the brain or spinal fluid - You have active hepatitis B, hepatitis C, HIV, or syphilis - You have had a stem cell transplant within the last 6 months - You have received CAR-T or other cell therapy before - You have severe heart disease or uncontrolled infection 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

BIOLOGICALBG1805

A single infusion of BG1805 Injection administered intravenously.


Locations(3)

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06118788


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