RecruitingPhase 1NCT05483491

KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung, and Other KK-LC-1 Positive Cancers


Sponsor

Christian Hinrichs

Enrollment

30 participants

Start Date

Sep 26, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase I clinical trial to determine the maximum tolerated dose (MTD) of KK-LC-1 TCR-T cells for the treatment of metastatic cancers that express KK-LC-1. Participants will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin. The safety profile and clinical response to treatment will be determined.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment called KK-LC-1 TCR-T cell therapy — a form of personalized immune cell therapy — in people with certain advanced cancers including gastric (stomach), breast (triple-negative), cervical, and lung cancers. The therapy uses a patient's own immune cells that are re-engineered to recognize and destroy cancer cells carrying a specific protein called KK-LC-1. **You may be eligible if...** - You are 18 or older - You have an advanced cancer (gastric, triple-negative breast, cervical, or lung) that is metastatic - Your tumor tests positive for the KK-LC-1 protein (at least 10% of tumor cells) - You carry a specific genetic marker called HLA-A*01:01 - You have already tried standard cancer treatments - You have measurable disease and adequate organ function - You have no more than 2 treated brain metastases that are stable **You may NOT be eligible if...** - Your tumor does not express KK-LC-1 - You do not have the HLA-A*01:01 genetic marker - You have not received prior standard therapies - You have active, untreated brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALKK-LC-1 TCR-T cells

Participants will receive a conditioning regimen consisting of cyclophosphamide and fludarabine. KK-LC-1 TCR-T cells will be administered as a single intravenous infusion.

DRUGAldesleukin

Aldesleukin 720,000 IU/kg IV every 8 hours will be preferentially administered as an inpatient within 24 hours after KK-LC-1 TCR-T cell infusion for up to 6 doses; however up to 24 hours may elapse between doses. Aldesleukin dosing will be stopped for aldesleukin-related grade 3 or greater toxicity other than flushing, fever, chills, or hemodynamic changes (tachycardia or hypotension) that respond to crystalloid infusion. Aldesleukin may also be stopped at any time at investigator discretion.


Locations(2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05483491


Related Trials