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

Part of paid clinical trials in Duarte, California.

Sponsor
Tr1X, Inc.
Study ID
NCT06462365
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Acute Lymphoblastic Leukemia, Adult B-Cell
  • Acute Lymphoblastic Leukemia, Adult T-Cell
  • Acute Myeloid Leukemia in Remission
  • Cancer Remission
  • Chronic Myelomonocytic Leukemia, in Remission
  • GVHD, Chronic
  • GVHD,Acute
  • GvHD
  • Hematologic Malignancy
  • Hematopoietic Stem Cell Transplant
  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TRX103 — BIOLOGICAL
    TRX103 infusion via central line.

Study Details

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.

Key Dates

Start date
Apr 8, 2024
Status verified
Oct 2024
Primary completion
Apr 15, 2026
Completion
Apr 15, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: TRX-103
    TRX-103 will be infused on time post hematopoietic stem cell transplant (HSCT).

Primary Outcome Measure

Safety and tolerability of TRX103 cell infusion through incidence of Adverse events. [ Time Frame: Up to a year ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
(800)826-4673
Dana-Farber Cancer InstituteBostonMassachusetts02215
John Koreth, MD
[email protected]
617-632-5138
University of MinnesotaMinneapolisMinnesota55455
Mark Juckett, MD
[email protected]
612-676-4200
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Miguel-Angel Perales, MD
[email protected]
646-608-3757
Fred Hutchinson Cancer CenterSeattleWashington98109
Filippo Milano, MD
[email protected]
206-667-5925

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CADana-Farber Cancer Institute· Boston, MAUniversity of Minnesota· Minneapolis, MNMemorial Sloan Kettering Cancer Center· New York, NYFred Hutchinson Cancer Center· Seattle, WA

Related Studies