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This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and evaluate the preliminary anti-tumor activity of LTZ-301 administered as a single agent in adult subjects with relapsed or refractory B-cell non-Hodgkin lymphoma
LTZ-301 is a bispecific antibody which is a Myeloid cell engager, which targets B-cells via CD79B, and triggers phagocytosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Subjects in this arm will participate in one (1) of eight (8) escalating defined dose level cohorts. Subjects will receive up to 54 weeks of LTZ-301 intravenously. |
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| Backfill Expansion | Experimental | Subjects may be dosed at levels previously declared safe to further explore safety, tolerability, and clinical activity at particular dose levels. |
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| Expansion | Experimental | A dose level will be selected to enroll additional subjects to explore safety, tolerability, and clinical activity for a selected lymphoma type. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LTZ-301 | Biological | LTZ-301 will be dosed IV, in initial 28 day cycles. First cycle dosing is every week. Second through fifth cycles are dosed every 2 weeks. Sixth cycle and beyond are 21 day cycles, and are dosed once every 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | To determine the incidence of adverse events according to CTCAE v5.0 and meeting protocol defined and dose limiting toxicity criteria. | Up to 54 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sherry Unabia | Contact | 669-207-0084 | sherry.unabia@ltztherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
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| LTZ-301 | Biological | LTZ-301will be dosed IV, as above |
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| LTZ-301 | Biological | LTZ-301will be dosed IV, as above |
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| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
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| Tennessee Oncology | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
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| ID | Term |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
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