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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
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.
Pembrolizumab will be administered after TIL infusion and continue every 3-6 weeks for up to 2 years.
University of California Irvine
Irvine, California, United States
Memorial Healthcare System
Hollywood, Florida, United States
University of Miami
Miami, Florida, United States
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
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Orlando Health
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Providence Cancer Institute
Portland, Oregon, United States
Allegheny Research Institute
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
...and 3 more locations