RecruitingPhase 1NCT06462365

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

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)

Sponsor

Tr1X, Inc.

Enrollment

36 participants

Start Date

Apr 8, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new approach to prevent graft-versus-host disease (GvHD) — a dangerous complication where donated immune cells attack the patient's own body — in people with blood cancers undergoing stem cell transplants from mismatched donors. **You may be eligible if...** - You are 18 or older with a blood cancer such as acute leukemia (ALL or AML), myelodysplastic syndrome (MDS), or CMML - You weigh at least 35 kg - You have a suitable mismatched related (haploidentical) or unrelated donor available - You are in good enough health to undergo a stem cell transplant (Karnofsky score ≥70%) - You have no active uncontrolled infections **You may NOT be eligible if...** - You have had a previous allogeneic stem cell transplant - You are HIV positive or have active hepatitis B or C - You have significant kidney, liver, lung, or heart problems - You have a history of thrombotic thrombocytopenic purpura (TTP) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.