Melanoma Clinical Trial

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

Summary

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

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05576077

Recruitment Status:

Recruiting

Sponsor:

Turnstone Biologics, Corp.

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There are 10 Locations for this study

See Locations Near You

University of California Irvine
Irvine California, 92868, United States More Info
Juan Miranda
Contact
714-509-2951
[email protected]
Ritesh Parajuli
Principal Investigator
University of Miami
Miami Florida, 33136, United States More Info
Yandhira Figueroa
Contact
305-243-5507
[email protected]
Lauren Miro
Contact
(305)243-4969
[email protected]
Orlando Health
Orlando Florida, 32806, United States More Info
Adult Oncology Patient Referral
Contact
[email protected]
Sajeve Thomas, MD
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Yvonne Nguyen
Contact
813-745-6869
[email protected]
Dae Won Kim
Principal Investigator
Norton Cancer Institute
Louisville Kentucky, 40202, United States More Info
NCI Research
Contact
502-629-2500
[email protected]
Contact
502-629-2500
Jaspreet Grewal, MD
Principal Investigator
Providence Healthcare Research Institute
Portland Oregon, 97213, United States More Info
Isa Ngirailemesang
Contact
503-215-2714
[email protected]
Patrick Rethwisch
Contact
[email protected]
Matthew Taylor
Principal Investigator
Allegheny Research Institute
Pittsburgh Pennsylvania, 15224, United States More Info
Shelly Evans
Contact
412-578-4905
[email protected]
Yazan Samhouri, MD
Principal Investigator
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Serdar Gurses
Contact
713-563-9710
[email protected]
Ashabari Sprenger
Contact
[email protected]
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Debra Pastorek
Contact
414-805-6837
[email protected]
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada More Info
Varia Sajeniouk
Contact
416-946-4501
[email protected]
Jeshani Sivakumar
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05576077

Recruitment Status:

Recruiting

Sponsor:


Turnstone Biologics, Corp.

How clear is this clinincal trial information?

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