Clinical Trial

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

Recruiting Phase 1
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Record status
This record was last updated April 15, 2025 (before its estimated April 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
The purpose of this Phase 1, first in human open-label study is to assess the safety and tolerability of TRX-103 in patients with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT). It is anticipated that up to 36 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time post HSCT.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-06-11; most recent amendment 2025-04-10.
Trial Details
NCT Number NCT06462365
Lead Sponsor Tr1X, Inc.
Conditions Hematologic Malignancy, GvHD, GVHD,Acute, GVHD, Chronic, Hematopoietic Stem Cell Transplant, Acute Lymphoblastic Leukemia, Adult B-Cell, Acute Lymphoblastic Leukemia, Adult T-Cell, Acute Myeloid Leukemia in Remission +3 more
Enrollment 36 participants
Start Date 2024-04-08
Primary Completion 2026-04-15 (estimated)
Study Completion 2027-04-15 (estimated)
Updated on ClinicalTrials.gov 2025-04-15