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

This study is testing a new treatment called KK-LC-1 TCR-T cells for people with advanced gastric, breast, cervical, or lung cancer that has spread (metastatic). This treatment uses your own immune cells, called T cells, which are specially trained to find and attack cancer cells that have a protein called KK-LC-1. Before receiving the KK-LC-1 TCR-T cells through a single infusion, you will have a preparation treatment with cyclophosphamide and fludarabine. You will also receive aldesleukin after the cell infusion. The main goal of this study is to find the highest safe dose of KK-LC-1 TCR-T cells. To join, your cancer must show the KK-LC-1 protein, and you must be at least 18 years old. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is a Phase 1 interventional study to find the maximum tolerated dose of KK-LC-1 TCR-T cells. It plans to enroll 30 participants.
What's involved
Participants will receive a conditioning regimen of cyclophosphamide and fludarabine, followed by a single intravenous infusion of KK-LC-1 TCR-T cells, and then up to 6 doses of aldesleukin.
Compensation
Not stated in the trial record.
Follow-up
The maximum tolerated dose of KK-LC-1 TCR-T cells will be measured at 30 days.

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NCT05483491

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Christian Hinrichs
~30 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:KK-LC-1 TCR-T cellsAldesleukin

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD) of KK-LC-1 TCR-T cells
Measured over 30 days
Gastric Cancer
Breast Cancer
Cervical Cancer
Lung Cancer
2 sites across 1 states
New Jersey2
  • Christian S Hinrichs, MD · PRINCIPAL_INVESTIGATOR · Rutgers Cancer Institute

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Eligibility criteria

Inclusion

HIV antibody negative
Hepatitis B antigen negative
Hepatitis C antibody negative or HCV RNA negative (i.e., no current HCV infection) 13. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the KK-LC-1 TCR-T cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability and meet the eligibility criteria for the protocol. 14. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) or NIH protocol 16C0061 (Rutgers 192202) for biospecimen collection study.
  • Maximum tolerated dose (MTD) of KK-LC-1 TCR-T cells30 days

    The highest dose level achieved according to the protocol-defined criteria for DLTs and determination of MTD.