A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors
A multicenter trial to investigate TBio-4101, an autologous, neoantigen-selected, tumor-reactive TIL product, in patients with advanced solid malignancies.
Checked against the public recordLast updated Mar 10, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Turnstone Biologics, Corp.
- Interventions being studied
- Biological: TBio-4101; Drug: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: * Advanced or metastatic breast carcinoma, colorectal adenocarcinoma, uveal melanoma, cutaneous melanoma, non-small cell lung cancer, or head and neck squamous cell carcinoma that has failed or is refractory to standard of care therapy * Have at least one target lesion that can be used for response assessments and have at least 1 tumor amenable for tissue harvest for TIL manufacturing. * ECOG performance status of 0 or 1 * Demonstrate adequate organ function * Additional inclusion criteria exist Key Exclusion Criteria: * Known additional malignancy that is progressing or has required active treatment within the past 3 years * Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive * Currently infected with HIV Type 1 and Type 2, hepatitis B virus (HBV), hepatitis C virus (HCV), treponema pallidum (e.g., syphilis), West Nile virus (WNV), Human T-lymphotropic virus types 1 or II (HTLV I/II), or cytomegalovirus (CMV) * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable * Serious cardiac condition, such as uncontrolled hypertension, concurrent congestive heart failure, prior history of Class III/IV cardiac disease (New York Heart Association \[NYHA\]), history of cardiac ischemia within the past 6 months, or prior history of cardiac arrhythmia requiring treatment. Patients who are \> 60 years of age must undergo cardiology clearance exam and cardiac stress test. * Prior cell therapy or organ transplant * History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, IL-2, or pembrolizumab, or any of their constituents * LVEF ≤ 45% * FEV1 ≤ 60% of predicted value and DLCO (corrected) \< 60% of predicted value * Chronic anti-coagulant therapy that cannot either be discontinued or temporarily changed * Additional exclusion criteria exist
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of California IrvineIrvine, California
- Memorial Healthcare SystemHollywood, Florida
- University of MiamiMiami, Florida
- Orlando HealthOrlando, Florida
- Moffitt Cancer CenterTampa, Florida
- University of ChicagoChicago, Illinois
- Norton Cancer InstituteLouisville, Kentucky
- Providence Cancer InstitutePortland, Oregon
- Allegheny Research InstitutePittsburgh, Pennsylvania
- MD Anderson Cancer CenterHouston, Texas
- Medical College of WisconsinMilwaukee, Wisconsin
- Princess Margaret Cancer CentreToronto, Ontario
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 10, 2025. Always confirm current availability with the study team.