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

NCT05576077 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-03-10

No results posted yet for this study

Summary

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

Conditions

Interventions

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 low dose radiation,TBio-4101, and IL-2.

DRUG

Pembrolizumab

Pembrolizumab will be administered after TIL infusion and continue every 3-6 weeks for up to 2 years.

Sponsors & Collaborators

  • Turnstone Biologics, Corp.

    lead INDUSTRY

Principal Investigators

  • Ines Verdon, MD · Turnstone Biologics, Corp.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-17
Primary Completion
2025-02-04
Completion
2025-02-24
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05576077 on ClinicalTrials.gov