Phase 1 Study to Test the Safety of TRX-103 for Patients With Blood Cancers Undergoing HLA-Mismatched Stem Cell Transplants

What this Trial Is About

Researchers are evaluating the safety and tolerability of TRX-103 in patients with hematological cancers undergoing hematopoietic stem cell transplantation HSCT using donors who are not fully matched. This Phase 1, open-label study aims to understand how TRX-103 affects patients after receiving HSCT, focusing on safety outcomes over a period of up to one year. The study plans to enroll up to 36 participants over 18 to 24 months. Participants will receive a single infusion of TRX-103 via a central line after their HSCT procedure. The infusion is given once, and the study observes patients for safety and potential side effects related to the treatment. This study involves no placebo or comparison group and is focused solely on evaluating TRX-103 in this specific transplant setting. Throughout the study, participants will be monitored through various safety assessments including tracking adverse events, examining stem cell engraftment and donor chimerism up to 42 days post-transplant, and testing for replication-competent lentivirus at 3, 6, and 12 months. Researchers will also assess occurrences of acute and chronic graft-versus-host disease GvHD and overall survival for up to a year. Participants will undergo regular visits and tests to track these outcomes during the study period.

Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)