Health Trials

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

ConditionsHematologic MalignancyGvHDGVHD,AcuteGVHD, ChronicHematopoietic Stem Cell TransplantAcute Lymphoblastic Leukemia, Adult B-CellAcute Lymphoblastic Leukemia, Adult T-CellAcute Myeloid Leukemia in RemissionMyelodysplastic SyndromesChronic Myelomonocytic Leukemia, in RemissionCancer Remission
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTr1X, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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 %.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • TRX103

Treatment groups

36 Participants
are divided into 1 treatment group

Sponsors and collaborators

Tr1X, Inc.

Lead sponsor

Source ClinicalTrials.gov