NCT05703204

A Study of QLF32101 in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

A Phase 1 Clinical Study on the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of QLF32101 in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to evaluate the safety,tolerability and preliminary efficacy of QLF32101 administered intravenously and subcutaneously in patients with R/R, AML.

Detailed description

This open label, first-in-human study consists of 2 parts. Part 1 consists of dose escalation cohorts and Part 2 is expansion cohort. The study population will include adult AML patients with relapse or refractory disease. In addition, in Part 2 medium and high-risk MDS patients are eligible. In Part 1, dose escalations cohorts are followed until dose-limiting toxicity (DLT) or a maximum tolerated dose (MTD) or RecommendedPart2Dose (RP2D) is defined. Dose escalation decisions will be made by the Data Review Committee and will be primarily guided by safety data observed through the end of Cycle 1, as well as on-going assessment of safety beyond Cycle 1 in later cohorts. Part 2 will begin once the MTD or RP2D is determined in Part 1. Part 2 will further characterize the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), immunogenicity and to assess preliminary efficacy of QLF32101.

Conditions

• Acute Myeloid Leukemia and Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	QLF32101	The dose is given weekly and observed for 28 days(DLT observation period).Single agent treatment.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-08-21
• Completion: 2024-12-21
• First posted: 2023-01-27
• Last updated: 2023-01-31

Locations

1 site across 1 country: China