Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs

Colorectal Cancer Clinical Trial

Official title:

Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Using the Sleeping Beauty System to Express T Cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects With Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05292859
• Other study ID #: TCR001-202
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: June 2039

Study information

• Verified date: March 2023
• Source: Alaunos Therapeutics
• Contact: Sandra Sinclair, MHA/Ed,RN
• Phone: 832-622-1699
• Email: ssinclair[@]alaunos.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2039
• Est. primary completion date: April 2039
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects treated with TCR-T cell drug product on study TCR001-201 or any other Alaunos TCR-T cell drug product study and have either completed their original treatment protocol or have discontinued early.

2. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

3. Subject must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

4. Subjects agree to allow clinical samples to be collected and stored at study site and/or Alaunos Therapeutics, Inc. (Alaunos) or designee for testing.

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.

Related Conditions & MeSH terms

• Adenocarcinoma of Lung
• Adenosquamous Cell Lung Cancer
• Cholangiocarcinoma
• Colorectal Cancer
• Gynecologic Cancer
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Ovary Neoplasm
• Pancreatic Cancer
• Squamous Cell Lung Cancer

Intervention

Biological:
• Neoantigen specific TCR-T cell drug product
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

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alaunos Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	To evaluate the long-term profile of persisting TCR-T cells.	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells	Incidence and duration of events of special interest, new Serious Adverse Events and new malignancies.; Incidence and duration of late onset adverse events; Proportion of subjects with adverse events leading to death; Incidence of subjects with resolution of adverse events/ serious adverse events and duration of events that began in study TCR001-201 or other clinical trial in which TCR-T cell drug product has been administered.	Up to 15 years post TCR-T cell drug product infusion
Secondary	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
Secondary	To determine overall survival.	Date of TCR-T cell drug product administration to death	Up to 15 years post TCR-T cell drug product infusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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