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

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Turnstone Biologics, Corp.
• Treatments: Pembrolizumab

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