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This study is a Phase 1 dose-escalation and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV111. The study will enroll patients with relapsed/refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UB-VV111 | Experimental | A single dose of UB-VV111 will be administered. |
|
| UB-VV111 + rapamycin | Experimental | A single dose of UB-VV111 will be administered followed by treatment with rapamycin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UB-VV111 | Genetic | UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with common adverse events (AEs) | Percentage of participants with commonly reported AEs overall and by severity | Up to 2 years after UB-VV111 administration |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) | Up to 2 years after UB-VV111 administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacob Garcia, MD | Contact | 425-873-8331 | jacob.garcia@umoja-biopharma.com | |
| Christine Dehner | Contact | christine.dehner@umoja-biopharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Jacob Garcia, MD | Umoja Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Not yet recruiting | Duarte | California | 91010 | United States |
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| rapamycin | Drug | Rapamycin is an FDA-approved drug. |
|
|
| The David and Etta Jonas Center for Cellular Therapy | Recruiting | Chicago | Illinois | 60637 | United States |
|
| Washington University School of Medicine/Siteman Cancer Center | Recruiting | St Louis | Missouri | 63110 | United States |
|
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198-6814 | United States |
|
| University of Cincinnatti Medical Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
|
| Fred Hutch Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
|
| Royal North Shore Hospital | Recruiting | Saint Leonards | New South Wales | 2065 | Australia |
|
| St. Vincent's Hospital Melbourne | Recruiting | Fitzroy | Victoria | 3065 | Australia |
|
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008223 | Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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