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

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ClinicalTrials.gov Identifier: NCT05576077
Recruitment Status : Recruiting
First Posted : October 12, 2022
Last Update Posted : February 3, 2023
Sponsor:
Information provided by (Responsible Party):
Turnstone Biologics, Corp.

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

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Uveal Melanoma Biological: TBio-4101 Drug: Pembrolizumab Phase 1

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients enrolled into a Cohort based on malignancy.
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 17, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Breast Cancer
Patients with locally advanced or metastatic breast cancer that has failed or is intolerant to standard of care therapies. Includes, HER2+, HER 2-, TNBC.
 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
Experimental: Colorectal carcinoma
Patients with advanced, metastatic colorectal adenocarcinoma who have failed or are intolerant to at least one line of therapy that included either irinotecan or oxaliplatin.
 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
Experimental: Uveal Melanoma
Patients with advanced, metastatic uveal melanoma.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 25 months ]
    The incidence of treatment-emergent adverse events will be tabulated using NCI CTCAE v5.0


Secondary Outcome Measures :
  1. Proportion of patients with a response (ORR) [ Time Frame: 25 months ]
    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

  2. Estimated Disease Control Rate (DCR) [ Time Frame: 25 months ]
    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

  3. Estimated Duration of Response (DoR) [ Time Frame: 25 months ]
    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,


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 exist

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 ≤ 45% or NYHA functional classification > 1
  • FEV1 ≤ 60% of predicted value and DLCO (corrected) < 60% of predicted value
  • Brain metastasis
  • Chronic anti-coagulant therapy that cannot either be discontinued or temporarily changed
  • Additional exclusion criteria exist
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05576077


Contacts
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Contact: Saundra Kirven 919- 451-4752 skirven@oncobay.com
Contact: Huguette Graham ClinicalOps@turnstonebio.com

Locations
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United States, Florida
Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Adult Oncology Patient Referral       r-adultonctrialreferral@orlandohealth.com   
Principal Investigator: Sajeve Thomas, MD         
United States, Pennsylvania
Allegheny Research Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Principal Investigator: Yazan Samhouri, MD         
Sponsors and Collaborators
Turnstone Biologics, Corp.
Investigators
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Study Director: Ines Verdon, MD Turnstone Biologics, Corp.
More Information
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Responsible Party: Turnstone Biologics, Corp.
ClinicalTrials.gov Identifier: NCT05576077    
Other Study ID Numbers: TBio-4101-001
First Posted: October 12, 2022    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Turnstone Biologics, Corp.:
MSS-CRC
TIL
Tumor infiltrating lymphocyte
TNBC
HR+ Breast
 ER+ Breast
MSI-CRC
personalized medicine
ocular melanoma
Additional relevant MeSH terms:
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Melanoma
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents