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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 10, 2025 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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
- 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
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.