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Clinical Trial 22284

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT05576077

Phase: Phase I
Principal Investigator: Kim, Dae Won

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Study Title

A Phase lb Study of TBio-4101 (Autologous Selected and Expanded Tumor-Infiltrating Lymphocytes [TIL]) and Pembrolizumab in Patients with Advanced Solid Tumor Malignancies (STARLING)


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.


Primary Objective: Define the safety and tolerability of NMA-LD chemotherapy, TBio-4101, aldesleukin (IL-2), and pembrolizumab Secondary objectives: -Determine ORR in all patients and within each treatment cohort RECIST 1.1 and iRECIST by an independent central imaging assessment -Evaluate DoR and DCR in all patients and within each treatment cohort using RECIST 1.1 and iRECIST by an independent central imaging assessment -Assess the feasibility of TBio-4101 in enrolled patients across indications (cumulative and by indication) Exploratory Objectives: -Evaluate TTB and PFS in all patients using RECIST 1.1 and iRECIST -Evaluate OS -Explore potential significance of T cell phenotype including TCR clonality and diversity and tumor antigen reactivity of TBio-4101 as they correlate with clinical outcome -Evaluate TBio-4101 engraftment, persistence, activation, phenotype, transcriptome profile and tumor infiltration and correlate these findings with clinical outcome -Compare baseline and on treatment determinants in the tumor by pathology and genomic analysis of pre- and on-treatment biopsies with clinical response -Assess post-PD anti-cancer therapy with responses and OS



Cell Therapy; Chemotherapy (NOS); Radiotherapy; Therapy (NOS)


Pembrolizumab (Keytruda); Radiotherapy (); TBio-4101 ()

Inclusion Criteria

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 apply

  • Exclusion Criteria

    Key Exclusion Criteria:

  • Ischemic heart disease (current or past), or clinically significant atrial or ventricular rhythm abnormality are excluded unless cardiac clearance is received.
  • Prior cell therapy or organ transplant
  • Have a primary or acquired immunodeficiency disorders
  • History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, IL-2, or pembrolizumab, or any of their constituents
  • LVEF 1
  • FEV1 > Brain metastasis
  • Chronic anti-coagulant therapy that cannot either be discontinued or temporarily changed
  • Additional exclusion criteria apply

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