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LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas

NCT03449108 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-22

No results posted yet for this study

Summary

This phase II trial studies how well autologous tumor infiltrating lymphocytes LN-145 (LN-145) or LN-145-S1 works in treating patients with ovarian cancer, triple negative breast cancer (TNBC), anaplastic thyroid cancer, osteosarcoma, or other bone and soft tissue sarcomas that do not respond to treatment (refractory) or that has come back (relapsed).

LN-145 is made by collecting and growing specialized white blood cells (called T-cells) that are collected from the patient's tumor. LN-145-S1 is made using a modified process that chooses a specific portion of the T-cells. The T cells may specifically recognize, target, and kill the tumor cells.

Conditions

  • Bone Sarcoma
  • Dedifferentiated Chondrosarcoma
  • Giant Cell Tumor of Bone
  • Malignancy in Giant Cell Tumor of Bone
  • Malignant Solid Neoplasm
  • Ovarian Carcinosarcoma
  • Platinum-Resistant Ovarian Carcinoma
  • Poorly Differentiated Thyroid Gland Carcinoma
  • Recurrent Osteosarcoma
  • Recurrent Ovarian Carcinoma
  • Refractory Osteosarcoma
  • Soft Tissue Sarcoma
  • Thyroid Gland Anaplastic Carcinoma
  • Thyroid Gland Squamous Cell Carcinoma
  • Undifferentiated High Grade Pleomorphic Sarcoma of Bone
  • Triple Negative Breast Cancer

Interventions

BIOLOGICAL

Aldesleukin

Given IV

BIOLOGICAL

Autologous Tumor Infiltrating Lymphocytes LN-145

Given IV

BIOLOGICAL

Autologous Tumor Infiltrating Lymphocytes LN-145-S1

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

BIOLOGICAL

Ipilimumab

Given IV

BIOLOGICAL

Nivolumab

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • Iovance Biotherapeutics, Inc.

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Amir A Jazaeri · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03449108 on ClinicalTrials.gov