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| ID | Type | Description | Link |
|---|---|---|---|
| 9BC08 | Other Grant/Funding Number | Florida Department of Health |
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| Name | Class |
|---|---|
| Florida Department of Health | OTHER_GOV |
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The purposes of the study are to determine the maximum tolerated dose (MTD) and effectiveness of Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion after an allogeneic hematopoietic cell transplant (alloHCT) to treat patients with Acute Myeloid Leukemia (AML).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level -1 | Experimental | Dose Level -1 may be used as a de-escalation dose level due to Dose Limiting Toxicities (DLTs) from Dose Level 1 Participants will receive 1.0 x 106 cells/kg (0.75-1.25 x 106 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion |
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| Dose Level 1 | Experimental | Participants will receive 5.0 x 106 cells/kg (3.75-6.25 x 106 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion |
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| Dose Level 2 | Experimental | Participants will receive 2.5 x 107 cells/kg (1.875-3.125 x 107 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion |
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| Dose Level 3 | Experimental | Participants will receive 1.0 x 108 cells/kg (0.75-1.25 x 108 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion |
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| Treatment at Maximum Tolerated Dose | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamma Delta T-Cell Infusion | Biological | Donor cells will be processed in a laboratory, where T-cell subtype called γδ (gamma delta) T-cells will be isolated and expanded in number. These T-cells expanded in a laboratory will be infused in participants who are otherwise at high risk of AML recurrence after alloHCT. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | Maximum Tolerated Dose will be determined by testing increasing doses of AAPC-expanded donor γδ T-cells. | Up to 12 months |
| Dose Expansion: Leukemia Free Survival | Leukemia-free survival is defined as the time from the date of start of treatment to the date of relapse of AML or death from any cause | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Graft Versus Host Disease (GVHD) | Number of participants with grade II-IV and III-IV acute GVHD within 6 weeks after infusion of Gamma T cells | at 6 weeks |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nelli Bejanyan, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Participants will receive Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells at the dose determined to be the Maximum Tolerated Dose, administered as a single infusion
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The length of time from start of treatment to death by any cause.
| Up to 12 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |