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Trial Title:
Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)
NCT ID:
NCT06462365
Condition:
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
Conditions: Official terms:
Leukemia
Neoplasms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Hematologic Neoplasms
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Leukemia-Lymphoma, Adult T-Cell
Myelodysplastic Syndromes
Conditions: Keywords:
AML
CMML
Stem Cell Transplant
B-ALL
T-ALL
Acute GvHD
Graft versus Host Disease
Chronic GvHD
MDS
Cellular Therapy
Autoimmune
T regulatory cells
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
TRX103
Description:
TRX103 infusion via central line.
Arm group label:
TRX-103
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
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. Males and Females Age ≥ 18 years.
3. Weight of ≥ 35 Kg.
4. Karnofsky performance status ≥ 70 %.
5. Available mismatched related (haploidentical) or unrelated donors for peripheral
blood stem cell (PBSC) donation.
6. Subjects must otherwise fulfill institutional criteria for eligibility to undergo
allogeneic stem cell transplantation.
7. Absence of uncontrolled bacterial, viral or fungal infection at time of enrollment.
8. Have adequate organ function.
9. Subjects > 65-year-old receiving MAC conditioning will only be eligible if they have
a HSCT-comorbidity index score < 5.
10. Subjects must be able to understand and sign informed consent and be willing and
able to complete all specified procedures and visits.
Exclusion Criteria:
1. Prior allogeneic bone marrow, peripheral blood, or cord blood HSCT.
2. Any subject with a history of significant renal, hepatic, pulmonary, or cardiac
dysfunction, or on treatment to support cardiac dysfunction.
3. HIV positive.
4. Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR
negative.
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. 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. 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. 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. Any serious illness, uncontrolled inter-current illness, psychiatric illness, active
or uncontrolled infection, or other medical condition or history, including
laboratory results.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Phone:
800-826-4673
Facility:
Name:
University of Minnesota
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mark Juckett, MD
Phone:
612-676-4200
Email:
ccinfo@umn.edu
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Filippo Milano, MD
Phone:
206-667-5925
Email:
fmilano@fredhutch.org
Start date:
April 8, 2024
Completion date:
April 15, 2027
Lead sponsor:
Agency:
Tr1X, Inc.
Agency class:
Industry
Source:
Tr1X, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06462365
