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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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • TRX103

    Biological/Vaccine

    TRX103 infusion via central line.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: TRX-103Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability of TRX103 cell infusion through incidence of Adverse events.

Time frame
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.

Time frame
Up to day 42
3

Safety of TRX103 determined by negative Replication Competent Lentivirus (RCL).

Time frame
At 3-month, 6-month, and 1-year.

Secondary outcomes

1

Incidence of Grade II-IV acute GvHD (aGvHD).

Time frame
Day 0 to Day +100 day
2

Incidence of Grade III-IV acute GvHD (aGvHD).

Time frame
Day 0 to Day +100 day
3

Incidence and severity of chronic GvHD (cGvHD)

Time frame
Day +100 through Day +365
4

Overall survival at Day +365.

Time frame
Up to a year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tr1X, Inc.

Lead sponsor

Source ClinicalTrials.gov
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