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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRX-103 | Experimental | TRX-103 will be infused on time post hematopoietic stem cell transplant (HSCT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRX103 | Biological | TRX103 infusion via central line. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of TRX103 cell infusion through incidence of Adverse events. | Up to a year | |
| Safety of TRX103 determined by stem cell engraftment and donor chimerism after HSCT measured by absolute neutrophil counts and percent donor chimerism. | Up to day 42 | |
| Safety of TRX103 determined by negative Replication Competent Lentivirus (RCL). | At 3-month, 6-month, and 1-year. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade II-IV acute GvHD (aGvHD). | Day 0 to Day +100 day | |
| Incidence of Grade III-IV acute GvHD (aGvHD). | Day 0 to Day +100 day | |
| Incidence and severity of chronic GvHD (cGvHD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tr1X Clinical Trials | Contact | 858-283-7879 | Tr1xClinicalTrials@Tr1x.bio |
| Name | Affiliation | Role |
|---|---|---|
| Maria Grazia Roncarolo, MD | Tr1X, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
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| Day +100 through Day +365 |
| Overall survival at Day +365. | Up to a year |
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
|
| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
|
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D007951 | Leukemia, Myeloid |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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