NCT06522373

Phase I Trial of MT-0169 in CD38+ Acute Leukemia With Relapsed/Refractory or Measurable Residual Disease

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To learn if MT-0169 is safe to give to patients with AML or T-ALL. The effects of this drug will also be studied.

Detailed description

Primary Objective: To study the safety and tolerability of MT-0169. Secondary Objectives: To study preliminary efficacy of MT-0169 in terms of morphologic and MRD response rates and survival outcomes. Exploratory Objectives: To determine the plasma concentration and pharmacokinetic (PK) parameters of MT-0169. To estimate proportion of MRD+ patients who achieved 1 log fold reduction in MRD burden. To explore, additional response and survival outcomes, potential biomarkers of response, resistance and impact on immune microenvironment.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	MT-0169	Given by Vein (IV)

Timeline

• Start date: 2024-10-21
• Primary completion: 2024-10-21
• Completion: 2024-10-21
• First posted: 2024-07-26
• Last updated: 2026-02-24

Regulatory

• FDA-regulated drug study