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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Specialized Immune Cells (nCTLs) and a Vaccine (Alpha-type-1 Polarized Dendritic Cells) in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT03735589

Stage II Fallopian Tube Cancer AJCC v8 Stage II Ovarian Cancer AJCC v8 Stage II Primary Peritoneal Cancer AJCC v8 +31 more

WITHDRAWN PHASE1/PHASE2

Biological Therapy in Treating Patients With Advanced Cancer

NCT00005956

Breast Cancer Gastric Cancer Ovarian Cancer

COMPLETED NA

Autologous CAR T-Cells Targeting the GD2 Antigen for Lung Cancer

NCT05620342

Lung Cancer Small Cell Lung Carcinoma Non Small Cell Lung Cancer

RECRUITING EARLY_PHASE1

TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors

NCT03778814

Nonsmall Cell Lung Cancer Solid Tumor, Adult

RECRUITING PHASE1

A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors

NCT02318394

Advanced Solid Tumors

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Neoantigen specific TCR-T cell drug product

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No