RECRUITING

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

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Conditions

Hematologic 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 RemissionAMLCMMLStem Cell TransplantB-ALLT-ALLAcute GvHDGraft versus Host DiseaseChronic GvHDMDSCellular TherapyAutoimmuneT regulatory cells

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2024-04-08
Study Completion:2027-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06462365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 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)
  2. 2. Males and Females Age ≥ 18 years.
  3. 3. Weight of ≥ 35 Kg.
  4. 4. Karnofsky performance status ≥ 70 %.
  5. 5. Available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation.
  6. 6. Subjects must otherwise fulfill institutional criteria for eligibility to undergo allogeneic stem cell transplantation.
  7. 7. Absence of uncontrolled bacterial, viral or fungal infection at time of enrollment.
  8. 8. Have adequate organ function.
  9. 9. Subjects \> 65-year-old receiving MAC conditioning will only be eligible if they have a HSCT-comorbidity index score \< 5.
  10. 10. Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.
  1. 1. Prior allogeneic bone marrow, peripheral blood, or cord blood HSCT.
  2. 2. Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction.
  3. 3. HIV positive.
  4. 4. Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.
  5. 5. 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.
  6. 6. 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.
  7. 7. Subjects with a previous history of Thrombotic Thrombocytopenic Purpura (TTP) or Hemolytic Uremic Syndrome (HUS) who are not good candidates for treatment with sirolimus.
  8. 8. 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).
  9. 9. Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results.

Contacts and Locations

Study Contact

Tr1X Clinical Trials
CONTACT
858-283-7879
Tr1xClinicalTrials@Tr1x.bio

Principal Investigator

Maria Grazia Roncarolo, MD
STUDY_DIRECTOR
Tr1X, Inc.

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Tr1X, Inc.

  • Maria Grazia Roncarolo, MD, STUDY_DIRECTOR, Tr1X, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-08
Study Completion Date2027-04-15

Study Record Updates

Study Start Date2024-04-08
Study Completion Date2027-04-15

Terms related to this study

Keywords Provided by Researchers

  • AML
  • CMML
  • Stem Cell Transplant
  • B-ALL
  • T-ALL
  • Acute GvHD
  • Graft versus Host Disease
  • Chronic GvHD
  • MDS
  • Cellular Therapy
  • Autoimmune
  • T regulatory cells

Additional Relevant MeSH Terms

  • 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