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

NCT06462365 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-04-15

No results posted yet for this study

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

BIOLOGICAL

TRX103

TRX103 infusion via central line.

Sponsors & Collaborators

  • Tr1X, Inc.

    lead INDUSTRY

Principal Investigators

  • Maria Grazia Roncarolo, MD · Tr1X, Inc.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-08
Primary Completion
2026-04-15
Completion
2027-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06462365 on ClinicalTrials.gov