RecruitingPhase 1Phase 2NCT07301866

A Study Testing an Improved Dose of UM171 to Help Make Cord Blood Transplants More Effective and Safe.

Single-site, Prospective, Open-label Phase I-II Study on Transplantation Using Cord Blood Treated With an Optimized Dose of UM171: Optimized ECT-001-CB.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Enrollment

7 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Leukemia, High Risk Myelodysplastic Syndromes, High Risk Hematologic Malignancy Requiring an Allogeneic Hematopoietic Stem Cell Transplant Lacking a Donor

Summary

This clinical study is testing a new way to improve stem cell transplants for adults with high-risk blood cancers, such as leukemia or myelodysplasia, who do not have a suitable donor. The transplant uses stem cells from umbilical cord blood that have been expanded in the lab using a molecule called UM171. Previous studies showed that UM171 helps these cells grow and work better, leading to faster blood count recovery and fewer complications. In this study, researchers are testing whether increasing the dose of UM171 during the lab expansion process can make the transplant less toxic. The hypothesis is that using a higher dose of UM171 to expand cord blood stem cells will help patients recover blood counts faster after transplant by improving the growth and function of the cells. This may lead to better immune recovery, fewer infections, shorter hospital stays, and improved overall outcomes. Only seven patients will be enrolled, and they will be followed for one year after their transplant.

Eligibility

Min Age: 18 YearsMax Age: 67 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an improved dose of a drug called UM171 to help make cord blood stem cell transplants more effective for patients with high-risk blood cancers or blood disorders who do not have a well-matched donor. UM171 helps expand (grow) the stem cells from cord blood before transplant so more cells are available, which may lead to a safer and more successful transplant. **You may be eligible if...** - You are between 18 and 67 years old - You have a high-risk blood cancer or blood disorder (such as leukemia or a bone marrow disorder) where a stem cell transplant is needed - You do not have a well-matched donor available (no matched sibling, haploidentical, or close-enough unrelated donor) - An appropriate cord blood unit is available that meets the study criteria - Your heart, lungs, and overall health are strong enough for a transplant **You may NOT be eligible if...** - You have a suitable matched donor available - Your organ function or overall health is too poor to tolerate a transplant - 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALECT-001-CB

UM171-expanded cord blood

Locations(1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

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

Visit

NCT07301866