Clinical trial · Interventional
Efficacy Study of a TXA127 to Reduce Graft-vs-Host Disease in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
Phase II Evaluation of the Efficacy of TXA127 (Angiotensin 1-7) to Reduce Acute Graft-vs.-Host Disease in Adults Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Change in drug product development strategy
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing allogeneic peripheral blood stem cell transplantation (PBSCT). The study will also evaluate the effects of TXA127 on incidence, severity and duration of mucositis; neutrophil engraftment and platelet recovery; platelet transfusion requirements; immune reconstitution; and duration of corticosteroid use. TXA127 has shown to be well tolerated by patients and appears to induce rapid production of neutrophils and platelets in the bloodstream, as well as increase the immune system components. TXA127 has also been shown reduce the severity of chemotherapy-induced mucositis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TXA127 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TXA127, blood draws, physical exams
- description
- Single-arm safety/efficacy trial of TXA127 (Angiotensin 1-7) in subjects undergoing allogeneic peripheral blood stem cell transplantation for the treatment of a variety of hematologic malignancies for whom there is no available therapy with substantive anti-disease effect. Treatment dose is 300 mcg/kg/day TXA127.
- interventionNames
- Drug: TXA127
Primary outcomes (1)
- measure
- Incidence of Grade II-IV acute graft-vs-host disease (aGVHD)
- timeFrame
- 100 days post-transplantation
- description
- Incidence of Grade II-IV acute graft-vs-host disease (aGVHD) will be assessed using clinical staging and grading criteria as defined in Przepiorka et al. (1995). Duration and severity of aGVHD will also be evaluated.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provided written informed consent. * ≥18 years of age. * Meet institutional standard criteria for PBSC transplantation * Myeloablative conditioning regimen * Histologically confirmed diagnosis of a hematologic malignancy. * Life expectancy of \>4 months. * Female subjects capable of reproduction (defined as a subject who has started menses) must agree to the following: 1) Use of an effective oral or IM contraceptive method during the course of the study and 2 months following the last administration of Investigational Product; and 2) must have a negative pregnancy test result within 7 days prior to first Investigational Product dose. Exclusion Criteria: * Uncontrolled infection at the time of transplant. * Pregnant or breastfeeding. * Known to be seropositive for HIV or HTLV-1. * Active CNS disease at the time of study enrollment. * Treatment with an investigational agent within 30 days of anticipated administration of the first dose of Investigational Product. * Current alcohol use, illicit drug use or any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule. * Any co-morbid condition which, in the view of the Principal Investigators, renders the subject at too high a risk from treatment complications and regimen-related morbidity/mortality. * Prophylactic treatment with palifermin for mucositis. * Subjects with a known sensitivity to any of the Investigational Product components.
References
Publications (0)
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