Actively Recruiting
Phase I Open Label Study Evaluating Safety and Tolerability of TRX-103 Cells in Patients With Hematological Malignancies Undergoing HLA-mismatched Hematopoietic Stem Cell Transplantation
Led by Tr1X, Inc. · Updated on 2025-04-15
36
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of TRX-103 in patients with hematological cancers undergoing hematopoietic stem cell transplantation (HSCT) using donors who are not fully matched. This Phase 1, open-label study aims to understand how TRX-103 affects patients after receiving HSCT, focusing on safety outcomes over a period of up to one year. The study plans to enroll up to 36 participants over 18 to 24 months. Participants will receive a single infusion of TRX-103 via a central line after their HSCT procedure. The infusion is given once, and the study observes patients for safety and potential side effects related to the treatment. This study involves no placebo or comparison group and is focused solely on evaluating TRX-103 in this specific transplant setting. Throughout the study, participants will be monitored through various safety assessments including tracking adverse events, examining stem cell engraftment and donor chimerism up to 42 days post-transplant, and testing for replication-competent lentivirus at 3, 6, and 12 months. Researchers will also assess occurrences of acute and chronic graft-versus-host disease (GvHD) and overall survival for up to a year. Participants will undergo regular visits and tests to track these outcomes during the study period.
CONDITIONS
Brief 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-ALL), Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia
- Male or female aged 18 years or older
- Weight at least 35 kilograms
- Karnofsky performance status score of 70% or higher
- Availability of mismatched related (haploidentical) or unrelated donor for peripheral blood stem cell donation
- Meets institutional criteria for allogeneic stem cell transplantation
- No uncontrolled bacterial, viral, or fungal infection at enrollment
- Adequate organ function
- For participants over 65 receiving myeloablative conditioning, HSCT-comorbidity index score less than 5
- Ability to understand and sign informed consent and complete study procedures and visits
You will not qualify if you...
- Prior allogeneic bone marrow, peripheral blood, or cord blood stem cell transplant
- History of significant kidney, liver, lung, or heart problems or treatment for heart dysfunction
- HIV positive status
- Positive hepatitis B surface antigen unless HBV PCR negative
- Positive hepatitis C antibody with positive confirmatory test unless treated and PCR negative
- Use of another investigational agent within 28 days before conditioning or unresolved treatment toxicities
- History of thrombotic thrombocytopenic purpura or hemolytic uremic syndrome not suitable for sirolimus treatment
- Pregnancy, breastfeeding, or planning pregnancy during study period (must use effective contraception)
- Any serious or uncontrolled illness, psychiatric condition, active infection, or other medical condition as judged by investigators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 100 days post-transplant
Participants receive an infusion of TRX-103 cells via central line following hematopoietic stem cell transplant (HSCT) to prevent graft-versus-host disease (GvHD).
1 infusion visit and multiple follow-up visits for safety assessments
Duration - Up to 1 year
Participants are monitored for safety, tolerability, and incidence of acute and chronic GvHD, as well as overall survival for up to one year after treatment.
Visits at Day 42, 3 months, 6 months, and 1 year post-treatment
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
1
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