Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem … (NCT06462365) | Clinical Trial Compass
RecruitingPhase 1
Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)
United States36 participantsStarted 2024-04-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Safety and tolerability of TRX103 cell infusion through incidence of Adverse events.
Timeframe: Up to a year
2
Safety of TRX103 determined by stem cell engraftment and donor chimerism after HSCT measured by absolute neutrophil counts and percent donor chimerism.
Timeframe: Up to day 42
3
Safety of TRX103 determined by negative Replication Competent Lentivirus (RCL).
✕. 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).