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Study is terminated by Sponsor decision due to recruitment challenges.
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Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA, and 177Lu-DOTA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD38-SADA:177Lu-DOTA Complex | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD38-SADA:177Lu-DOTA Complex | Drug | The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA. Both will be administered as an IV infusions. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A) | 4 weeks | |
| Occurrence of dose limiting toxicities during the DLT evaluation period (Part B) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Scottsdale | Arizona | 85258 | United States | ||
| City of Hope |
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| Duarte |
| California |
| 91010 |
| United States |
| Corewell Health-BAMF Health | Grand Rapids | Michigan | 49503 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Stony Brook Cancer Center | Stony Brook | New York | 11794 | United States |
| East Carolina University Leo W. Jenkins Cancer Center | Greenville | North Carolina | 27834 | United States |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| 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 |
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