NCT06462365

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

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Tr1X, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BIOLOGICAL	TRX103	TRX103 infusion via central line.

Timeline

• Start date: 2024-04-08
• Primary completion: 2026-04-15
• Completion: 2027-04-15
• First posted: 2024-06-17
• Last updated: 2025-04-15

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study