RecruitingPhase 1NCT07014449

Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia

An Open-Label, Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of WBC100 Capsules in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Sponsor

Hangzhou Weben Pharma Co., Ltd

Enrollment

18 participants

Start Date

Nov 3, 2024

Study Type

INTERVENTIONAL

Conditions

Hematologic Malignancy AML (Acute Myelogenous Leukemia)Refractory Acute Myeloid Leukemia Adult Acute Myeloid Leukemia Relapsed Acute Myelogenous Leukemia C-Myc

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of WBC100 capsules in patients with relapsed or refractory acute myeloid leukemia (R/R AML). The main questions it aims to answer are: * What is the safety and tolerability profile of WBC100 in R/R AML patients? * Can WBC100 effectively induce remission in R/R AML patients? Participants will: * Take WBC100 capsules orally once daily in 28-day treatment cycles; * Undergo regular safety assessments, including adverse event monitoring and laboratory tests; * Provide blood samples for pharmacokinetic (PK) analysis; * Have their remission status and efficacy evaluated according to the ELN2022 criteria.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new capsule called WBC100 in patients with acute myeloid leukemia (AML) — a type of blood cancer — whose disease came back or did not respond to prior treatments. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of relapsed or refractory AML - Your blood counts and organ function (liver, kidneys, heart) are within acceptable ranges - Your general health is good enough to participate (ECOG score 0–2) - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - You have a specific subtype of leukemia called acute promyelocytic leukemia (APL) - You relapsed after a bone marrow transplant with significant transplant complications - You have had major surgery or unhealed wounds in the past 28 days - You have significant heart rhythm problems (prolonged QTc interval) - You have been in another clinical trial within the past 28 days 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGWBC100 QD

WBC100 will be administered orally as capsules once daily in 28-day cycles. The dose-escalation phase follows an accelerated titration combined with the traditional '3+3' design.

Locations(1)

The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07014449

Related Trials

211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome

NCT036709661 location

A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia

NCT070120445 locations

Response to Influenza Vaccination in Pediatric Oncology Patients

NCT053842881 location

Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT

NCT05429632108 locations

CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

NCT044931641 location