BridgeMD
Prevention study for Hematologic Malignancy
Official title Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)
ClinicalTrials.gov ID: NCT06462365
What this study is testing
What is TRX103?
TRX103 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hematologic malignancy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people with one of the following hematologic malignancies: Acute Lymphoblastic Leukemia (B- or T-ALL), Acute Myeloid Leukemia (AML) and...
- Males and Females Age ≥ 18 years.
- Weight of ≥ 35 Kg.
- Karnofsky performance status ≥ 70 %.
- Available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation.
You likely can't join if
- Prior allogeneic bone marrow, peripheral blood, or cord blood HSCT.
- Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction.
- HIV positive.
- Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.
- Positive hepatitis-C antibody with positive Recombinant Immunoblot Assay (RIBA) or PCR unless the subject has received curative anti-viral treatment...
- Received another investigational agent for treatment of disease understudy within 28 days (or 5 half-lives, whichever is shorter) of conditioning...
See the full eligibility criteria
- people with one of the following hematologic malignancies: Acute Lymphoblastic Leukemia (B- or T-ALL), Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
- Males and Females Age ≥ 18 years.
- Weight of ≥ 35 Kg.
- Karnofsky performance status ≥ 70 %.
- Available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation.
- people must otherwise fulfill institutional criteria for eligibility to undergo allogeneic stem cell transplantation.
- Absence of uncontrolled bacterial, viral or fungal infection at time of enrollment.
- Have adequate organ function.
- people \> 65-year-old receiving MAC conditioning will only be eligible if they have a HSCT-comorbidity index score \< 5.
- people must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.
- Prior allogeneic bone marrow, peripheral blood, or cord blood HSCT.
- Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction.
- HIV positive.
- Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.
- Positive hepatitis-C antibody with positive Recombinant Immunoblot Assay (RIBA) or PCR unless the subject has received curative anti-viral treatment and confirmed negative viral load by PCR.
- Received another investigational agent for treatment of disease understudy within 28 days (or 5 half-lives, whichever is shorter) of conditioning and/or have not recovered from treatment related toxicities.
- people with a previous history of Thrombotic Thrombocytopenic Purpura (TTP) or Hemolytic Uremic Syndrome (HUS) who are not good candidates for treatment with sirolimus.
- people that are pregnant, breast feeding or aim to become pregnant during the study period. (people must agree to use a highly effective method of contraception).
- Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Boston, Massachusetts, United States; Minneapolis, Minnesota, United States; New York, New York, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.