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NCT06462365 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Myelodysplastic Syndromes and Hematologic Malignancy, sponsored by Tr1X.

Recruiting
Registry status
Phase 1
Development phase
36
Enrollment target
5
Study locations

NCT06462365 is a Phase 1 study of Myelodysplastic Syndromes and Hematologic Malignancy that is actively recruiting participants, run by Tr1X. The registered enrollment target is 36 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (87% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT06462365, a Phase 1 study of Myelodysplastic Syndromes and Hematologic Malignancy, is actively recruiting participants, sponsored by Tr1X.

RECRUITING
Registry status
Phase 1
Development phase
36 participants
Enrollment target
5
Study locations

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 Studied

Myelodysplastic Syndromes Hematologic Malignancy Acute Myeloid Leukemia in Remission Hematopoietic Stem Cell Transplant GvHD GVHD,Acute Chronic Myelomonocytic Leukemia, in Remission GVHD, Chronic Acute Lymphoblastic Leukemia, Adult B-Cell Acute Lymphoblastic Leukemia, Adult T-Cell

Interventions

  • BIOLOGICAL TRX103

Study Locations (5)

California

  • City of Hope - Duarte

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Minnesota

  • University of Minnesota - Minneapolis

New York

  • Memorial Sloan Kettering Cancer Center - New York

Washington

  • Fred Hutchinson Cancer Center - Seattle

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2024-04-08
Est. Completion 2027-04-15
Phase Phase 1

Sponsor

Tr1X

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06462365

The ClinicalTrials.gov registry entry for NCT06462365 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (87% lower). The listed sponsor is Tr1X, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention - of which TRX103 is the first listed.

NCT06462365 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Massachusetts, Minnesota.

Frequently Asked Questions

What is clinical trial NCT06462365 about?

NCT06462365 is a clinical study titled "Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)". 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...

What is the current status of trial NCT06462365?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2024-04-08. Estimated completion is 2027-04-15.

What conditions does trial NCT06462365 study?

This clinical trial studies the following conditions: Myelodysplastic Syndromes, Hematologic Malignancy, Acute Myeloid Leukemia in Remission, Hematopoietic Stem Cell Transplant, GvHD.

What interventions are being tested in trial NCT06462365?

The interventions under investigation include: TRX103 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06462365?

This trial is sponsored by Tr1X, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06462365 being conducted?

This trial has 5 study locations across California, Massachusetts, Minnesota, New York, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.