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The trial was discontinued due to sponsor's decision and not a consequence of any safety concern.
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A Phase 1 dose-finding study of Universal Chimeric Antigen Receptor T-cells targeting cluster of differentiation (CD) 123 (UCART123) administered intravenously to patients with relapsed or refractory Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), followed by a dose expansion phase in relapsed or refractory BPDCN patients or newly diagnosed BPDCN patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation | Experimental | A single intravenous administration of UCART123. Dose escalation in Part 1 will include 3 doses ranging from 6.25 x 10^5 cells/kg to 6.25 x 10^6 cells/kg and continue until the Recommended Phase 2 Dose (RP2D) is identified. |
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| Part 2: Dose Expansion | Experimental | A single intravenous administration of UCART123 at the RP2D. 2 Cohorts: Patients with Relapsed/Refractory BPDCN and Newly Diagnosed BPDCN. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCART123 | Biological | Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor given as a single dose following a lymphodepleting regimen. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence, nature, and severity of adverse events and serious adverse events | Through day 84 |
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Main Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ioana Kloos, MD | Cellectis S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D000099067 | Blastic Plasmacytoid Dendritic Cell Neoplasm |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007938 | Leukemia |
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| D008223 |
| Lymphoma |
| D009371 | Neoplasms by Site |
| D012878 | Skin Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |