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Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Engineered using the Sleeping Beauty System to Express T cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects with Solid Tumors
This is a prospective observational, non-interventional study for the long-term follow-up of safety and efficacy for subjects who have received autologous T cells engineered using the Sleeping Beauty System to express T cell receptors (TCRs) reactive against cancer-specific mutations (neoantigen specific TCR-T cells). In this study, subjects will be followed for up to 15 years after initial TCR-T cell drug product administration for evaluation of delayed adverse events (AEs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rollover subjects from Alaunos Therapeutics TCR-T cell drug product interventional studies | This is a rollover protocol designed to provide long-term follow-up to all subjects previously enrolled in any Alaunos Therapeutics autologous, neoantigen specific TCR-T cell drug product interventional studies. Patients will be followed for up to 15 years after dosing of Alaunos Therapeutics autologous, neoantigen specific TCR-T cell drug product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoantigen specific TCR-T cell drug product | Biological | No study drug is administered in this study. Patients who have received Neoantigen specific TCR-T cell drug product will be evaluated in this trial for long-term safety and efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells | Incidence and duration of new related adverse events | Up to 2 years post TCR-T cell drug product infusion |
| To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells |
| Up to 15 years post TCR-T cell drug product infusion |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate translational hypotheses related to TCR-T cell persistence. | Duration of TCR-T cell drug product persistence by vector copy number (VCN). | Up to 15 years post TCR-T cell drug product infusion |
| To determine overall survival. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the long-term profile of persisting TCR-T cells. | Primary and secondary malignancy: presence of TCR-T cells in tumor samples biopsy and autopsy. | Up to 15 years post TCR-T cell drug product infusion |
| To evaluate the long-term profile of persisting TCR-T cells. |
Inclusion Criteria:
Exclusion Criteria:
1. Subjects that were consented to this LTFU study but did not receive TCR-T cell drug product on study TCR001-201 will be excluded. No other exclusions are permitted.
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Patients will be enrolled following either the completion or early termination/discontinuation from Study NCT05194735 or any protocol in which patients were administered Neoantigen specific TCR-T cell drug product. Patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. Patients will be followed for up to 15 years post TCR-T cell drug product infusion and will continue to be monitored for safety, immunogenicity and efficacy.
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| Name | Affiliation | Role |
|---|---|---|
| Scott Kopetz, MD, PhD | MD Anderson | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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Peripheral blood samples will be collected for the analysis of TCR-T cell drug product persistence by vector copy number (VCN). The collection of tumor tissue samples is to enable the investigation of changes that may occur within the tumor associated with progression. Tissue samples will be analyzed by NGS (e.g., WES, RNA-Seq, etc.) to evaluate T cell infiltration, TCR-T cell drug product infiltration, presence of HLA alleles and presence of tumor-specific neoantigens. Additional confirmatory analyses of these samples (e.g., immunohistochemistry (IHC) or in situ hybridization (ISH)to verify target expression) may be performed based on emergent data and sufficient sample availability.
Date of TCR-T cell drug product administration to death
| Up to 15 years post TCR-T cell drug product infusion |
| To continue the clinical efficacy assessment of TCR-T cell product. | Overall response by RECIST 1.1 for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies | Up to 15 years post TCR-T cell drug product infusion |
| To continue the clinical efficacy assessment of TCR-T cell product. | Overall response by iRECIST for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies | Up to 15 years post TCR-T cell drug product infusion |
| To continue the clinical efficacy assessment of TCR-T cell product. | Duration of response (DoR) for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies | Up to 15 years post TCR-T cell drug product infusion |
| To continue the clinical efficacy assessment of TCR-T cell product. | Progression-free survival (PFS) for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies | Up to 15 years post TCR-T cell drug product infusion |
Determine the TCR-T persistence, defined by the duration of TCR-T cell drug product measurable by vector copy number (VCN) in peripheral blood samples |
| Up to 15 years post TCR-T cell drug product infusion |
| To evaluate the long-term profile of persisting TCR-T cells. | Transposon insertion-site clonality in TCR-T cells over time. | Up to 15 years post TCR-T cell drug product infusion |
| To evaluate the long-term profile of persisting TCR-T cells. | To evaluate changes in T cell infiltration that may occur within the tumor associated with disease progression following TCR-T cell infusion | Up to 15 years post TCR-T cell drug product infusion |
| To evaluate the long-term profile of persisting TCR-T cells. | To evaluate infiltration of TCR-T cells within tumor tissue following disease progression | Up to 15 years post TCR-T cell drug product infusion |
| To evaluate the long-term profile of persisting TCR-T cells. | To evaluate the presence of HLA alleles within the tumor associated with disease progression following TCR-T cell infusion | Up to 15 years post TCR-T cell drug product infusion |
| To evaluate the long-term profile of persisting TCR-T cells. | To evaluate changes in the presence of tumor-specific neoantigens within the tumor associated with disease progression following TCR-T cell infusion | Up to 15 years post TCR-T cell drug product infusion |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D018281 | Cholangiocarcinoma |
| D010051 | Ovarian Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
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