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.

View Full Description

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. 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, 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

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05576077

Recruitment Status:

Recruiting

Sponsor:

Turnstone Biologics, Corp.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 3 Locations for this study

See Locations Near You

Orlando Health
Orlando Florida, 32806, United States More Info
Adult Oncology Patient Referral
Contact
[email protected]
Sajeve Thomas, MD
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
Allegheny Research Institute
Pittsburgh Pennsylvania, 15224, United States More Info
Shelly Evans
Contact
412-578-4905
[email protected]
Yazan Samhouri, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05576077

Recruitment Status:

Recruiting

Sponsor:


Turnstone Biologics, Corp.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.