OncRef

Clinical Trial: NCT06462365

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

Status:

RECRUITING

Phase:

Phase 1

Lead Sponsor:Tr1X, Inc.
Information Provided By:Tr1X, Inc.
Last Update Posted:2025-04-15

Study Overview

Brief 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.

Official Title

Phase I, First in Human, Open Label Study to Evaluate Safety and Tolerability of TRX103 Cells in Subjects With Hematological Malignancies Undergoing HLA-mismatched Related or Unrelated Hematopoietic Stem Cell Transplantation (HSCT)

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, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, in Remission, Cancer Remission

Intervention / Treatment

  • Biological: TRX103

Other Study ID Numbers

  • TRX103-01

Start Date (Actual)

2024-04-08

Primary Completion Date (Estimated)

2026-04-15

Study Completion Date (Estimated)

2027-04-15

Enrollment (Estimated)

36

Study Type

Interventional

Phase

Phase 1