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TRX103 for Preventing GvHD After Stem Cell Transplant

This study is testing TRX103 to see if it is safe and tolerable for people with certain blood cancers (like leukemia or myelodysplastic syndrome) who are having a stem cell transplant. Stem cell transplants can sometimes lead to a serious complication called Graft-versus-Host Disease (GvHD), where the new immune cells attack the patient's body. This study will give TRX103 as a one-time infusion after the transplant. Researchers will be looking closely at any side effects and how well the new stem cells engraft (take hold) in your body. Up to 36 participants will be enrolled.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know you are receiving TRX103. It plans to enroll up to 36 participants.
What's involved
You would receive a one-time infusion of TRX103 after your stem cell transplant. Your safety will be monitored for up to a year, with specific checks for engraftment up to 42 days, and other safety measures at 3 months, 6 months, and 1 year.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to a year after receiving TRX103.

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NCT06462365

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

Recruiting
PHASE1Ages 18+InterventionalPrevention
Tr1X, Inc.
~36 participants
Updated 2025-04-15 on ClinicalTrials.gov
What's tested:TRX103

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of TRX103 cell infusion through incidence of Adverse events.
Measured over Up to a year
+2 more outcomes measured

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

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic Syndrome

Where it's being run

5 sites across 5 states
California1
Massachusetts1
Minnesota1
New York1
Washington1

Study leadership

  • Maria Grazia Roncarolo, MD · STUDY_DIRECTOR · Tr1X, Inc.

Who to contact

Tr1X Clinical Trials
[email protected]
858-283-7879
Email the study team

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What this trial measures

  • Safety and tolerability of TRX103 cell infusion through incidence of Adverse events.Up to a year
  • Safety of TRX103 determined by stem cell engraftment and donor chimerism after HSCT measured by absolute neutrophil counts and percent donor chimerism.Up to day 42
  • Safety of TRX103 determined by negative Replication Competent Lentivirus (RCL).At 3-month, 6-month, and 1-year.