Trial Title:
A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors
NCT ID:
NCT05576077
Condition:
Breast Cancer
Colorectal Cancer
Uveal Melanoma
Cutaneous Melanoma
Non-Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Melanoma
Squamous Cell Carcinoma of Head and Neck
Pembrolizumab
Conditions: Keywords:
MSS-CRC
TIL
Tumor infiltrating lymphocyte
TNBC
HR+ Breast
ER+ Breast
MSI-CRC
personalized medicine
ocular melanoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients enrolled into a Cohort based on malignancy.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
TBio-4101
Description:
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.
Arm group label:
Breast Cancer
Arm group label:
Colorectal carcinoma
Arm group label:
Cutaneous Melanoma
Arm group label:
Head and Neck Squamous Cell Carcinoma
Arm group label:
Non-Small Cell Lung Cancer
Arm group label:
Uveal Melanoma
Other name:
TIL, autologous, tumor-reactive, T-cell product
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab will be administered after TIL infusion and continue every 3-6 weeks for up
to 2 years.
Arm group label:
Breast Cancer
Arm group label:
Colorectal carcinoma
Arm group label:
Cutaneous Melanoma
Arm group label:
Head and Neck Squamous Cell Carcinoma
Arm group label:
Non-Small Cell Lung Cancer
Arm group label:
Uveal Melanoma
Other name:
Keytruda
Summary:
A multicenter trial to investigate TBio-4101, an autologous, neoantigen-selected,
tumor-reactive TIL product, in patients with advanced solid malignancies.
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. 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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California Irvine
Address:
City:
Irvine
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Juan Miranda
Phone:
714-509-2951
Email:
jlmirand@hs.uci.edu
Investigator:
Last name:
Ritesh Parajuli
Email:
Principal Investigator
Facility:
Name:
Memorial Healthcare System
Address:
City:
Hollywood
Zip:
33021
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Andres Alvarez
Phone:
954-276-9321
Email:
andralavarez@mhs.net
Contact backup:
Last name:
Shoria Martelly
Phone:
954-844-8732
Email:
smartelly@mhs.net
Investigator:
Last name:
Atif Hussein
Email:
Principal Investigator
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Miro
Phone:
305-243-7590
Email:
lem183@med.miami.edu
Investigator:
Last name:
Agustin Pimentel, MD
Email:
Principal Investigator
Facility:
Name:
Orlando Health
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Contact:
Last name:
Adult Oncology Patient Referral
Email:
r-adultonctrialreferral@orlandohealth.com
Investigator:
Last name:
Sajeve Thomas, MD
Email:
Principal Investigator
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612-9497
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yvonne Nguyen
Phone:
813-745-6869
Email:
yvonne.nguyen@moffitt.org
Investigator:
Last name:
Dae Won Kim
Email:
Principal Investigator
Facility:
Name:
University of Chicago
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cesar Mireles
Email:
Cesar.Mireles@bsd.uchicago.edu
Contact backup:
Last name:
Ligia Monterroza
Email:
Ligia.Monterroza@bsd.uchicago.edu
Investigator:
Last name:
Daniel Olson, MC
Email:
Principal Investigator
Facility:
Name:
Norton Cancer Institute
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
NCI Research
Phone:
502-629-2500
Phone ext:
19460
Email:
earlyphase-nciresearch@nortonhealthcare.org
Contact backup:
Phone:
502-629-2500
Investigator:
Last name:
Jaspreet Grewal, MD
Email:
Principal Investigator
Facility:
Name:
Providence Healthcare Research Institute
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Isa Ngirailemesang
Phone:
503-215-2714
Email:
Isa.Ngirailemesang@providence.org
Contact backup:
Last name:
Patrick Rethwisch
Email:
Patrick.rethwisch@providence.org
Investigator:
Last name:
Matthew Taylor
Email:
Principal Investigator
Facility:
Name:
Allegheny Research Institute
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lindsey Brown
Phone:
412-578-5426
Email:
Lindsey.brown@ahn.org
Contact backup:
Last name:
Frankie Houser
Phone:
(412) 578-1646
Email:
Frankie.Houser2@ahn.org
Investigator:
Last name:
Yazan Samhouri, MD
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amber Sherrard
Phone:
713-563-9710
Email:
AESherrard@mdanderson.org
Contact backup:
Last name:
Ashabari Sprenger
Email:
amukherjee1@mdanderson.org
Investigator:
Last name:
Aung Nang, MD
Email:
Principal Investigator
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Windowski, BS
Phone:
414-805-8937
Email:
lwinkowski@mcw.edu
Contact backup:
Phone:
(414) 805-5136
Investigator:
Last name:
Sailaja Kamaraju, MD
Email:
Principal Investigator
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2C1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Shivali Suri
Phone:
416-946-4501
Phone ext:
2639
Email:
Shivali.Suri@uhn.ca
Contact backup:
Last name:
Jeshani Sivakumar
Email:
jeshani.sivakumar@uhn.ca
Investigator:
Last name:
Marcus Butler, MD
Email:
Principal Investigator
Facility:
Name:
Montreal University Hospital Center
Address:
City:
Montréal
Zip:
H2X 0C1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Adeline Hamon
Email:
adeline.hamon.chum@ssss.gouv.qc.ca
Contact backup:
Last name:
Dr. Simon Turcotte
Email:
simon.turcotte.med@ssss.gouv.qc.ca
Investigator:
Last name:
Simon Turcotte, MD
Email:
Principal Investigator
Start date:
January 17, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Turnstone Biologics, Corp.
Agency class:
Industry
Source:
Turnstone Biologics, Corp.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05576077
