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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Phase I clinical trial to determine the Phase II dose of autologous TIL 1383I TCR gene modified T Cells using a retrovirus. This is a novel National Cancer Institute (NCI) funded investigator initiated therapy for patients with advanced melanoma.
This is a Phase 1 dose escalation study designed to find the highest dose of TIL 1383I TCR transduced T cells that can safely be given. Three cohorts of 3 patients will be treated with increasing doses of TIL 1383I TCR transduced T cells. Patients will be monitored clinically and immunologically for a year after infusion. Subjects in Cohort 1 will receive 7.5 X 10^6/kg TIL 1383I TCR transduced T cells. Subjects in Cohort 2 will receive 2.5 x 10^7/kg TIL 1383I TCR transduced T cells. Subjects in Cohort 3 will receive 7.5 x 10^7/kg TIL 1383I TCR transduced T cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escalating Doses | Experimental | Three patients will be treated at the first & each subsequent dose level. Patients will be observed for 30 days post T cell infusion. If there was one DLT in the first 3 patients, an additional 3 patients will be treated at that level. If no additional DLTs are observed (for a total of 1 DLT in 6 patients) then the dose will be escalated. If two patients in the first 3 patients at a dose level experience a DLT, the dose will be de-escalated to the previous level & an additional 3 patients will be enrolled at that level if 6 have not yet been treated at that level. The maximum tolerated dose (MTD) is defined as the highest dose at which 0 or 1 patient in six has experienced a DLT. If 2 or 3 patients in the first 3 patients experience a DLT at the first dose level, the study will terminate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escalating Doses | Biological | Subjects will receive a single infusion of autologous bulk TIL 13831 TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 13831 TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4 + and CD8+ T Cells expressing the TIL 13831 TCR. Subjects in Cohort 1 will receive 7.5 x 10^6/kg TIL 1383I TCR transduced T cells. Subjects in Cohort 2 will receive 2.5 x 10^7/kg TIL 1383I TCR transduced T cells. Subjects in Cohort 3 will receive 7.5 x 10^7/kg TIL 1383I TCR transduced T cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Approximately 18 patients with Grade 2 through Grade 5 Adverse Events that are related to study drug, graded according to NCI CTCAE Version 4.0 | Establish a recommended phase II dose of autologous T cell receptor transduced T cells by evaluating unexpected Grade 2 adverse events through Grade 5 regardless of attribution, all toxicities attributed to the cells, and all incidences of intubation including the duration and reason for intubation. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Immunologic changes in T cell count | Change in T cell count from baseline to 4 weeks. | Baseline and 4 weeks |
| Audiologic changes of Grade 2 or higher as related to study drug, graded according to NCI CTCAE Version 4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Nishimura, PhD | Contact | 708-327-3241 | mnishimura@lumc.edu | |
| Ann Lau Clark, RN, MSN | Contact | 708-327-3221 | alausch@luc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Nishimura, PhD | Loyola University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Recruiting | Maywood | Illinois | 60153 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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Potential auditory changes from baseline to 4 weeks.
| Baseline and 4 weeks |
| Ophthalmologic changes or development of Uveitis of Grade 2 or higher as related to study drug, graded according to NCI CTCAE Version 4.0 | Potential visual changes from baseline to 4 weeks. | Baseline and 4 weeks |
| CT scans or physical examination from approximately 18 patients will be used to evaluate for a clinical objective response using RECIST Guideline Version 1.1 | CT scan or physical examination will be used to evaluate for a clinical objective response in patients who have received transduced T Cells at scheduled time points. | Baseline and 4 weeks |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |