A Phase 1 interventional study of TBio-4101 and Pembrolizumab in Breast Cancer, Colorectal Cancer and Uveal Melanoma, sponsored by Turnstone Biologics, Corp.. Terminated at 13 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by Turnstone Biologics, Corp. · Phase 1, Interventional, and Treatment
A multicenter trial to investigate TBio-4101, an autologous, neoantigen-selected, tumor-reactive TIL product, in patients with advanced solid malignancies.
This is a Phase 1 study to investigate TBio-4101. TBio-4101 is an autologous tumor infiltrating lymphocyte (TIL) therapy that utilizes tumor specific antigens to select, sort, and expand patient-specific tumor-reactive T-cells to be reinfused into the patient. The adoptive cell therapy is further enhanced through the use of non-myeloablative chemotherapy prior to TIL infusion, followed by the TIL plus IL-2 infusion. Low-dose radiation therapy is administered prior to and after TIL plus IL-2 infusion. Pembrolizumab is provided after the resolution of IL-2 toxicities. The trial is open to solid tumors of varying tumor mutational burdens.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 31 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Turnstone Biologics, Corp. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Patients with locally advanced or metastatic breast cancer that has failed or is intolerant to standard of care therapies. Includes, HER2+, HER 2-, TNBC.
Biological: TBio-4101 · Drug: Pembrolizumab
Patients with advanced, metastatic colorectal adenocarcinoma who have failed or are intolerant to at least one line of therapy that included either irinotecan or oxaliplatin.
Biological: TBio-4101 · Drug: Pembrolizumab
Patients with advanced, metastatic uveal melanoma.
Biological: TBio-4101 · Drug: Pembrolizumab
Patients with cutaneous melanoma who have experienced disease progression following a PD-1 or PD-L1 inhibitor.
Biological: TBio-4101 · Drug: Pembrolizumab
Patients with non-small cell lung cancer who have experienced disease progression following platinum containing chemotherapy and/or PD-1 or PD-L1 inhibitor.
Biological: TBio-4101 · Drug: Pembrolizumab
* Patients with head and neck squamous cell carcinoma who have received no prior therapy for metastatic disease * Patients with head and neck squamous cell carcinoma who are PD-1/PD-L1 inhibitor naïve at the time of TIL harvest and will be treated with TBio-4101 at the time of progression, inadequate response or intolerance to the PD-1/PD-L1 inhibitor-based standard of care regimen given on study.
Biological: TBio-4101 · Drug: Pembrolizumab
TBio-4101 is an autologous selected and expanded tumor infiltrating lymphocyte (TIL) product generated following ex vivo expansion of tumor reactive TIL population found in tumor harvest. After preparation with non-myeloablative lymphodepletion chemotherapy (cyclophosphamide and fludarabine) followed by low dose radiation,TBio-4101, and IL-2.
Also known as: TIL, autologous, tumor-reactive, T-cell product
Pembrolizumab will be administered after TIL infusion and continue every 3-6 weeks for up to 2 years.
Also known as: Keytruda
Safety and tolerability
The incidence of treatment-emergent adverse events will be tabulated using NCI CTCAE v5.0
Time frame: 25 months
Proportion of patients with a response (ORR)
Percentage of all patients and within each cancer indication with a CR or PR as assessed by the independent central radiologist using RECIST 1.1 and iRECIST
Time frame: 25 months
Estimated Disease Control Rate (DCR)
Portion of patient whose best response is a CR, PR, or stable disease (SD) as assessed by the independent central radiologist using RECIST v1.1 and iRECIST
Time frame: 25 months
Estimated Duration of Response (DoR)
Duration of response, as measured in weeks, that patients with a CR or PR have no progressed (PD), as assessed by the independent central radiologist using RECIST v1.1 and iRECIST,
Time frame: 25 months
This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Turnstone Biologics, Corp.