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RECRUITING
NCT05361174
PHASE1/PHASE2

A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer

Sponsor: Iovance Biotherapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).

Official title: A Phase 1/2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2022-07-20

Completion Date

2027-06

Last Updated

2024-12-05

Healthy Volunteers

No

Interventions

BIOLOGICAL

IOV-4001

A tumor sample is resected from each participant and cultured ex-vivo to manufacture IOV-4001. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with IOV-4001, and followed by IL-2.

Locations (10)

The Angeles Clinic and Research Institute

Los Angeles, California, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

The University of Kansas Cancer Center

Westwood, Kansas, United States

University of Louisville

Louisville, Kentucky, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States