RecruitingPhase 1Phase 2NCT06580301

Study of YK012 in B-cell Acute Lymphoblastic Leukemia

An Open-Label, Multi-Center, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YK012 in Participants With B-cell Acute Lymphoblastic Leukemia

Sponsor

Excyte Biopharma Ltd

Enrollment

46 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

B-cell Acute Lymphoblastic Leukemia

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YK012 administered as monotherapy in participants with B-cell acute lymphoblastic leukemia (B-ALL).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial tests a new drug called YK012 for people with B-cell acute lymphoblastic leukemia (B-ALL), a fast-growing cancer of the blood and bone marrow. The study aims to find a safe dose and assess early signs of effectiveness. **You may be eligible if...** - You have been diagnosed with B-cell ALL - Your cancer has come back or has not responded to prior treatments - You meet minimum physical performance and organ function requirements - Your legal guardian can provide consent if you are a minor **You may NOT be eligible if...** - You have active, uncontrolled infections (including certain viral infections) - You have had a stem cell transplant recently without adequate recovery time - You have serious heart, liver, or kidney problems 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

DRUGYK012

The treatments include 2 cycles of induction treatment, 3 cycles of consolidation treatment, and up to 5 cycles of maintenance treatment.

Locations(12)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06580301

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