Actively Recruiting
Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)
Led by Tr1X, Inc. · Updated on 2025-04-15
36
Participants Needed
5
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute lymphoblastic leukemia (B- or T-cell), acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia
- Male or female aged 18 years or older
- Weight of 35 kilograms or more
- Karnofsky performance status of 70% or higher
- Available mismatched related (haploidentical) or unrelated donor for peripheral blood stem cell donation
- Eligible for allogeneic stem cell transplantation per institutional criteria
- No uncontrolled bacterial, viral, or fungal infections at enrollment
- Adequate organ function
- Subjects older than 65 receiving myeloablative conditioning must have a HSCT-comorbidity index score less than 5
- Ability to understand and sign informed consent and willingness to complete all study procedures and visits
You will not qualify if you...
- Prior allogeneic bone marrow, peripheral blood, or cord blood stem cell transplantation
- History of significant renal, liver, lung, or heart dysfunction or treatment supporting cardiac dysfunction
- HIV positive status
- Positive hepatitis B surface antigen (unless HBV PCR negative)
- Positive hepatitis C antibody with positive confirmatory test unless cured and with negative viral load
- Use of other investigational agents within 28 days before conditioning or unresolved treatment toxicities
- History of thrombotic thrombocytopenic purpura or hemolytic uremic syndrome not suitable for sirolimus treatment
- Pregnant, breastfeeding, or planning pregnancy during the study (must use effective contraception)
- Serious or uncontrolled illnesses, psychiatric conditions, infections, or other medical conditions or abnormal lab results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
5
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
T
Tr1X Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here