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

Launched by TR1X, INC. · Jun 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TRX-103 for patients with certain blood cancers, like Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, who are getting a special type of transplant called hematopoietic stem cell transplantation (HSCT). The main goal is to see if TRX-103 is safe and well-tolerated when given to patients after their transplant. The trial will include up to 36 participants, and the treatment will be given just once after the transplant procedure.

To participate, individuals must be at least 18 years old, weigh at least 35 kg (about 77 pounds), and have specific types of blood cancers. They should also have a suitable donor for the stem cell transplant and not have any uncontrolled infections or serious health issues affecting their organs. Participants will need to understand the study details and provide consent. During the trial, they can expect to undergo regular check-ups and tests to monitor their health and the effects of the treatment. This trial is currently recruiting participants, and it aims to gather important information about the safety of TRX-103 for future use.

Gender

ALL

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.