A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors (STARLING)

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)

  • Clinical Trial Information

    Trial Contact: Donaldson, Karin M; Frankos, Marie; Djuro, Victor; Caldwell, Chloe M; Ribacchi, Stephanie

  • IRB No: 22.222.10

    Protocol Abbrev: TBio-4101-001

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase I

    Age Group: Adult

    Secondary Protocol No: TBio-4101-001

    Treatment: 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 TBio-4101 and IL-2. Other Name: TIL, autologous, tumor-reactive, T-cell product Drug: Pembrolizumab Pembrolizumab will be administered after TIL infusion and continue every 3 weeks for up to 2 years. Other Name: Keytruda

    Therapies Involved: Medication ID: NCT05576077

  • Objective

    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. Pembrolizumab is provided after the resolution of IL-2 toxicities. The trial is open to solid tumors of varying tumor mutational burdens.

  • Key Eligibility

    Key Inclusion Criteria:
    *Advanced or metastatic breast carcinoma, colorectal adenocarcinoma, or uveal melanoma 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