A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors
Reason given: Sponsor decision
Key facts
- Where
- Chicago, Hollywood, Houston, Irvine, Louisville, Miami, Milwaukee, Orlando, Pittsburgh, Portland, and Tampa, United StatesSee the 11 sites
- Phase
- Phase 1
Where in United States
- University of ChicagoChicago, United StatesNo longer taking part
- Memorial Healthcare SystemHollywood, United StatesNo longer taking part
- MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- University of California, IrvineIrvine, United StatesNo longer taking part
- Norton Cancer InstituteLouisville, United StatesNo longer taking part
- University of MiamiMiami, United StatesNo longer taking part
- Medical College of WisconsinMilwaukee, United StatesNo longer taking part
- Orlando HealthOrlando, United StatesNo longer taking part
- Allegheny Research InstitutePittsburgh, United StatesNo longer taking part
- Providence Cancer InstitutePortland, United StatesNo longer taking part
- Moffitt Cancer CenterTampa, United StatesNo longer taking part
Trial details
- Who runs it
- Turnstone Biologics, Corp.
- Trial code
- NCT05576077
- Record updated
- 10 March 2025
- Original description
A multicenter trial to investigate TBio-4101, an autologous, neoantigen-selected, tumor-reactive TIL product, in patients with advanced solid malignancies.Read full original descriptionShow less
A Phase 1b Study of TBio-4101 (Autologous Selected and Expanded Tumor-Infiltrating Lymphocytes [TIL]) and Pembrolizumab in Patients With Advanced Solid Tumor Malignancies (STARLING)
A multicenter trial to investigate TBio-4101, an autologous, neoantigen-selected, tumor-reactive TIL product, in patients with advanced solid malignancies.
Inclusion: 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.
Exclusion: Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive; Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable; Prior cell therapy or organ transplant; Chronic anti-coagulant therapy that cannot either be discontinued or temporarily changed; Known additional malignancy that is progressing or has required active treatment within the past 3 years; 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); History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, IL-2, or pembrolizumab, or any of their constituents; 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; LVEF ≤ 45%; FEV1 ≤ 60% of predicted value and DLCO (corrected) < 60% of predicted value; Additional exclusion criteria exist.