NCT06714591

Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1

A Multicenter, Open-Label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: SystImmune Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia.

Detailed description

BL-M11D1-HM-101 is a multi-center, Phase 1 study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia. This study will be conducted in two parts (dose escalation, and dose finding). Cohort A will be dosed on Days 1, 8,15 of a continuous 28-day treatment cycle. The cohort has different dose groups. Cohort B will be dosed on Days 1, 4, 7 or 8 of a continuous 28-day treatment cycle. The cohorts have different dose groups.

Conditions

• Relapsed/Refractory Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	BL-M11D1	The study includes 2 parts: Part 1 Dose escalation and Dose Finding

Timeline

• Start date: 2024-12-19
• Primary completion: 2026-12-31
• Completion: 2027-03-30
• First posted: 2024-12-03
• Last updated: 2025-12-31

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study