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

Recruiting now · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT06462365

Run by

Tr1X, Inc.

People needed

36

Starts

2024-04-08

Expected to finish

2027-04-15

Last updated by the study team

2025-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects 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.
• Subjects 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.
• Subjects > 65-year-old receiving MAC conditioning will only be eligible if they have a HSCT-comorbidity index score < 5.
• Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.

You may not qualify 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 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.
• Subjects with a previous history of Thrombotic Thrombocytopenic Purpura (TTP) or Hemolytic Uremic Syndrome (HUS) who are not good candidates for treatment with sirolimus.
• Subjects that are pregnant, breast feeding or aim to become pregnant during the study period. (Subjects 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.

Where it is running

• City of Hope — Duarte, California, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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