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Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer

NCT04111510 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-11-21

Study results available
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Summary

This study will investigate the safety and efficacy of TIL therapy in patients with metastatic TNBC who have progressed on at least one and no more than three prior systemic anticancer therapies.

Conditions

Interventions

DRUG

Tumor infiltrating lymphocytes (TIL) LN-145

The TIL autologous therapy with LN-145 is comprised of the following steps: 1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product; 2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility; 3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards); 4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization); 5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).

Sponsors & Collaborators

  • Iovance Biotherapeutics, Inc.

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Michael Hurwitz, MD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-23
Primary Completion
2023-01-30
Completion
2023-05-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04111510 on ClinicalTrials.gov