Trials / Terminated
TerminatedNCT05576077
A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors
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)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Turnstone Biologics, Corp. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
A multicenter trial to investigate TBio-4101, an autologous, neoantigen-selected, tumor-reactive TIL product, in patients with advanced solid malignancies.
Detailed description
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.
Conditions
- Breast Cancer
- Colorectal Cancer
- Uveal Melanoma
- Cutaneous Melanoma
- Non-Small Cell Lung Cancer
- Head and Neck Squamous Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TBio-4101 | 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. |
| DRUG | Pembrolizumab | Pembrolizumab will be administered after TIL infusion and continue every 3-6 weeks for up to 2 years. |
Timeline
- Start date
- 2023-01-17
- Primary completion
- 2025-02-04
- Completion
- 2025-02-24
- First posted
- 2022-10-12
- Last updated
- 2025-03-10
Locations
13 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05576077. Inclusion in this directory is not an endorsement.