RecruitingPhase 1NCT06714591

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.

Sponsor

SystImmune Inc.

Enrollment

120 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Conditions

Relapsed/Refractory Acute Myeloid Leukemia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called Bl-M11D1 in people with acute myeloid leukemia (AML) — a cancer of the blood — that has come back or stopped responding to standard treatments. The drug targets a protein called CD33, which is found on leukemia cells. **You may be eligible if...** - You are 18 or older with relapsed or refractory AML that is CD33-positive - Your leukemia returned or did not respond after standard treatment - You are in reasonably good health (ECOG performance status 0–2) - Your liver and kidney function are within acceptable ranges - You agree to use effective contraception during and for 7 months after treatment **You may NOT be eligible if...** - Your AML does not express the CD33 protein - You have unresolved serious side effects from previous treatments - You have severe liver or kidney problems - You are pregnant or breastfeeding 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.

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Interventions

DRUGBL-M11D1

The study includes 2 parts: Part 1 Dose escalation and Dose Finding

Locations(14)

City of Hope

Duarte, California, United States

UCLA Ronald Reagan Medical Center

Los Angeles, California, United States

Yale Cancer Center, Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

Moffitt Cancer Center

Tampa, Florida, United States

START Midwest/The Cancer and Hematology Center

Grand Rapids, Michigan, United States

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

WVCI Oncology Associates of Oregon

Eugene, Oregon, United States

SCRI -TriStar BMT

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Texas Oncology, P.A.

San Antonio, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Oncology & Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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

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NCT06714591

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