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

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