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CAR T-cell Therapy

KK-LC-1 TCR Gene Therapy for Cancer

Phase 1
Recruiting
Led By Scott M Norberg, D.O.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have histologically or cytologically confirmed KK-LC-1 positive epithelial cancer (KK-LC-1 positivity assay performed at Rutgers Cancer Institute of New Jersey). KK-LC-1 expression will be determined by immunohistochemistry (IHC). KK-LC-1 score of 25% or greater will be considered positive.
Participants with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Participants with surgically resected brain metastases are eligible.
Must not have
Participants on active systemic immunosuppressive therapy that cannot be safely withheld.
Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to treat cancer by targeting KK-LC-1, a cancer germline antigen, with T cell therapy. Researchers will test the safety of different doses of KK-LC-1 TCR T cells plus aldesleukin to treat metastatic or refractory/recurrent KK-LC-1 positive cancers.

Who is the study for?
Adults over 18 with certain advanced KK-LC-1 positive epithelial cancers (like gastric, breast, cervical, lung) that have spread or are unresponsive to treatment. They must have normal organ function and no severe allergies to the trial drugs. Participants can't be on immunosuppressive therapy, have a compromised immune system or serious heart conditions.
What is being tested?
The trial is testing T Cell Receptor Gene Therapy targeting KK-LC-1 antigen in cancer cells. It involves modifying patients' T cells to fight cancer and giving them back via injection after chemotherapy preparation and alongside a growth factor called aldesleukin.
What are the potential side effects?
Possible side effects include reactions from the modified T cells attacking other body parts, complications from chemotherapy like nausea and hair loss, as well as fatigue and potential infection risks due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is KK-LC-1 positive, confirmed by a test.
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I have up to 3 brain metastases treated with surgery or radiosurgery and stable for 1 month.
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I have either received the first round of standard treatment or cannot receive any available treatments known to extend life.
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My genetic test shows I have the HLA-A 01:01 type.
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It has been over 4 weeks since my last systemic therapy before getting KK-LC-1 TCR T cells.
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My cancer is spreading, can't be cured with current treatments, and tests positive for KK-LC-1.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I am older than 18 years.
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My blood and organ functions are within the required ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on immunosuppressive therapy that cannot be stopped safely.
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I have a condition that significantly weakens my immune system.
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I do not have any current infections alongside my main illness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To determine the maximally tolerated dose of KK-LC-1 TCR T cells plus aldesleukin for the treatment of KK-LC-1 plus cancers.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment at dose levels 1 through 7Experimental Treatment4 Interventions
Non-myeloablative, lymphocyte depleting preparative regimen, followed by KK-LC-1 TCR T cells plus aldesleukin at escalating doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1860

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,925 Previous Clinical Trials
41,017,901 Total Patients Enrolled
Scott M Norberg, D.O.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
2,285 Total Patients Enrolled

Media Library

KK-LC-1 TCR (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05035407 — Phase 1
Lung Cancer Antigen 1 (KL-1) Research Study Groups: Treatment at dose levels 1 through 7
Lung Cancer Antigen 1 (KL-1) Clinical Trial 2023: KK-LC-1 TCR Highlights & Side Effects. Trial Name: NCT05035407 — Phase 1
KK-LC-1 TCR (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05035407 — Phase 1
Lung Cancer Antigen 1 (KL-1) Patient Testimony for trial: Trial Name: NCT05035407 — Phase 1
~11 spots leftby Apr 2025
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