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

a study on Breast Cancer Colorectal Cancer Ocular Melanoma Skin Cancer/Melanoma Lung Cancer Non-Small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma Solid Tumor Head and Neck Cancer

Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at UC Irvine
Dates
study started
completion around
Principal Investigator
by Ritesh Parajuli (uci)

Description

Summary

A multicenter trial to investigate TBio-4101, an autologous, neoantigen-selected, tumor-reactive TIL product, in patients with advanced solid malignancies.

Official Title

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)

Details

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.

Keywords

Breast Cancer, Colorectal Cancer, Uveal Melanoma, Cutaneous Melanoma, Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, MSS-CRC, TIL, Tumor infiltrating lymphocyte, TNBC, HR+ Breast, ER+ Breast, MSI-CRC, personalized medicine, ocular melanoma, Melanoma, Squamous Cell Carcinoma of Head and Neck, Pembrolizumab, TBio-4101, Colorectal carcinoma

Eligibility

You can join if…

Open to people ages 18-70

  • Advanced or metastatic breast carcinoma, colorectal adenocarcinoma, uveal melanoma, cutaneous melanoma, non-small cell lung cancer, or head and neck squamous cell carcinoma 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

You CAN'T join if...

  • Known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive
  • Currently infected with HIV Type 1 and Type 2, hepatitis B virus (HBV), hepatitis C virus (HCV), treponema pallidum (e.g., syphilis), West Nile virus (WNV), Human T-lymphotropic virus types 1 or II (HTLV I/II), or cytomegalovirus (CMV)
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable
  • Serious cardiac condition, such as uncontrolled hypertension, concurrent congestive heart failure, prior history of Class III/IV cardiac disease (New York Heart Association [NYHA]), history of cardiac ischemia within the past 6 months, or prior history of cardiac arrhythmia requiring treatment. Patients who are > 60 years of age must undergo cardiology clearance exam and cardiac stress test.
  • Prior cell therapy or organ transplant
  • History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, IL-2, or pembrolizumab, or any of their constituents
  • LVEF ≤ 45%
  • FEV1 ≤ 60% of predicted value and DLCO (corrected) < 60% of predicted value
  • Chronic anti-coagulant therapy that cannot either be discontinued or temporarily changed
  • Additional exclusion criteria exist

Locations

  • University of California Irvine accepting new patients
    Irvine California 92868 United States
  • Providence Healthcare Research Institute accepting new patients
    Portland Oregon 97213 United States

Lead Scientist at University of California Health

  • Ritesh Parajuli (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 18 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Turnstone Biologics, Corp.
ID
NCT05576077
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated