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NCT06714591 · ClinicalTrials.gov registry record · Phase 1
Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1
A Phase 1 study of Relapsed/Refractory Acute Myeloid Leukemia, sponsored by SystImmune.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 14
- Study locations
NCT06714591: Recruiting Phase 1 study of Relapsed/Refractory Acute Myeloid Leukemia, sponsored by SystImmune.
NCT06714591 is a Phase 1 study of Relapsed/Refractory Acute Myeloid Leukemia that is actively recruiting participants, run by SystImmune. The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06714591, a Phase 1 study of Relapsed/Refractory Acute Myeloid Leukemia, is actively recruiting participants, sponsored by SystImmune.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 14
- Study locations
Study 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.
Primary Outcome
DLTs are defined as any of the following events that are not clearly due to the underlying disease, disease progression, or extraneous causes: * Any treatment-emergent adverse event (TEAE) of ≥ Grade 3 except those due to disease progression or extraneous cause * Any TEAE that leads to dose reduction or withdrawal Nonhematologic toxicities * Death * Hy's law cases * Grade ≥3 nonhematologic toxicities (with exceptions) Hematologic toxicity * Grade 4 thrombocytopenia or neutropenia lasting \>42 d
Conditions Studied
Interventions
- DRUG BL-M11D1
Study Locations (14)
California
- City of Hope - Duarte
- UCLA Ronald Reagan Medical Center - Los Angeles
Ohio
- Oncology Hematology Care Clinical Trials, LLC - Cincinnati
- The Ohio State University Comprehensive Cancer Center - Columbus
Texas
- MD Anderson Cancer Center - Houston
- Texas Oncology, P.A. - San Antonio
Virginia
- Virginia Cancer Specialists - Fairfax
- Oncology & Hematology Associates of Southwest Virginia, Inc. - Roanoke
Connecticut
- Yale Cancer Center, Smilow Cancer Hospital at Yale New Haven - New Haven
Florida
- Moffitt Cancer Center - Tampa
Michigan
- START Midwest/The Cancer and Hematology Center - Grand Rapids
Oregon
- WVCI Oncology Associates of Oregon - Eugene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-12-19 |
| Est. Completion | 2027-03-30 |
| Phase | Phase 1 |
What NCT06714591 shows while recruiting
NCT06714591 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).
The record links to 1 condition, with Relapsed/Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which BL-M11D1 is the first listed.
NCT06714591 lists 14 locations in 10 states (California, Ohio, Texas).
Frequently Asked Questions
What is clinical trial NCT06714591 about?
NCT06714591 is a clinical study titled "Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1". 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.
What is the current status of trial NCT06714591?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2024-12-19. Estimated completion is 2027-03-30.
What conditions does trial NCT06714591 study?
This clinical trial studies the following conditions: Relapsed/Refractory Acute Myeloid Leukemia.
What interventions are being tested in trial NCT06714591?
The interventions under investigation include: BL-M11D1 (DRUG).
Who is sponsoring clinical trial NCT06714591?
This trial is sponsored by SystImmune, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06714591 being conducted?
This trial has 14 study locations across California, Connecticut, Florida, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Relapsed/Refractory Acute Myeloid Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06714591's enrollment target sits among peer trials
120 479th of 2000 higher than 1,503 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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