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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,172 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the KK-LC-1 TCR been tested in any preceding experiments?

"Currently, the number of trials that are actively researching KK-LC-1 TCR stands at 913 with 163 being in Phase 3. Most studies for this treatment can be found in Philadelphia, Pennsylvania but there is a total of 28673 sites running experiments on KK-LC-1 TCR."

Answered by AI

Are there any opportunities for enrollment in this experiment at present?

"Per clinicaltrials.gov, this research project is actively seeking volunteers for participation. It was initially made available on March 8th 2022 and the most recent update occurred November 16th of the same year."

Answered by AI

Does the immunotherapy of KK-LC-1 TCR pose any potential risks to human health?

"There is limited clinical data available to support the safety and efficacy of KK-LC-1 TCR, so it attained a score of 1."

Answered by AI

What diseases has KK-LC-1 TCR been especially effective at curing?

"KK-LC-1 TCR is a suitable therapeutic intervention for multiple sclerosis, leukemia, myelocytic acute and retinoblastoma."

Answered by AI

How many individuals are taking part in this experiment at the most?

"Affirmative. On clinicaltrials.gov, the information confirms that this study is currently searching for patients to enroll in the trial which was created on March 8th 2022 and last modified on November 16th 2022. The total sample size of 100 will be recruited from one centre."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Triple negative breast cancer stage 4. I have applied for other trials with the NIC and they have access to my patient information. I have also supplied my blood for the HLA test. I have not had any treatments since reoccurrence. I doctor with Mayo and they only have 2 trials that fit me cancer. None of those are targeted immunotherapy. I feel like that is the direction I want to go.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers
2022. "T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05035407.
~31 spots leftby Apr 2025
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