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Recruiting NCT06462365

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

Phase I Interventional Hematologic Malignancy GvHD GVHD,Acute GVHD, Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TRX103.
Who it may be relevant to
Registry conditions: Hematologic Malignancy, GvHD, GVHD,Acute, GVHD, Chronic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase I, First in Human, Open Label Study to Evaluate Safety and Tolerability of TRX103 Cells in Subjects With Hematological Malignancies Undergoing HLA-mismatched Related or Unrelated Hematopoietic Stem Cell Transplantation (HSCT)

Overview

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.

Interventions

  • Biological TRX103
    TRX103 infusion via central line.

Primary outcome measures

  • Safety and tolerability of TRX103 cell infusion through incidence of Adverse events. [Time frame: Up to a year]
  • 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]
  • Safety of TRX103 determined by negative Replication Competent Lentivirus (RCL). [Time frame: At 3-month, 6-month, and 1-year.]
Secondary outcome measures (4)
  • Incidence of Grade II-IV acute GvHD (aGvHD). [Time frame: Day 0 to Day +100 day]
  • Incidence of Grade III-IV acute GvHD (aGvHD). [Time frame: Day 0 to Day +100 day]
  • Incidence and severity of chronic GvHD (cGvHD) [Time frame: Day +100 through Day +365]
  • Overall survival at Day +365. [Time frame: Up to a year]

Eligibility criteria

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.
  • 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.

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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 5 centers
  • City of Hope — Duarte
  • Dana-Farber Cancer Institute — Boston
  • University of Minnesota — Minneapolis
  • Memorial Sloan Kettering Cancer Center — New York
  • Fred Hutchinson Cancer Center — Seattle

Publications

  • Uyeda MJ, Re A, Tang C, McLaughlin M, Humes D, Sexton S, Freeborn R, Villalba I, Nugent K, Adams J, Wei J, Breton M, Paliard X, Richter M, Roncarolo MG, Bjordahl R. Engineering allogeneic type 1 regulatory T cells: a scalable, off-the-shelf platform for restoring immune tolerance. Front Immunol. 2026 Jul 9;17:1848770. doi: 10.3389/fimmu.2026.1848770. eCollection 2026. PMID 42495646

Identifiers

NCT: NCT06462365 · TRX103-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗