Experimental gene therapy targets common cancer protein
NCT ID NCT05035407
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested a new type of immunotherapy for people with advanced cancers that carry a specific protein called KK-LC-1. The treatment involved collecting a patient's own immune cells, modifying them in the lab to better recognize and attack cancer cells, and infusing them back along with a drug to help them survive. The study aimed to find a safe dose and was open to adults with gastric, breast, cervical, lung, or other epithelial cancers that tested positive for KK-LC-1.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KK-LC-1 T cell receptor (TCR) gene therapy plus aldesleukin (IL-2)
- What this could lead to
- If successful, this could point toward a new treatment option for several hard-to-treat cancers that express the KK-LC-1 protein.
- What could go wrong
- This is an early phase 1 trial focused on safety, not effectiveness. The trial was terminated, so results may be limited. Side effects from chemotherapy, cell infusion, and aldesleukin can be severe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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36 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Jul 2025
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Participants must have histologically or cytologically confirmed Kita-Kyushu Lung Cancer Antigen-1 (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 must be HLA-A 01 (human leukocyte antigen serotype within HLA-A "A" serotype group) by low resolution typing, and HLA-A 01:01 by one of the high-resolution type results * Measurable metastatic or refractory/recurrent KK-LC-1+ epithelial cancer (determined by Immunohistochemistry (IHC). * All participants must have received prior first line standard therapy or be ineligible to receive available therapies with known survival benefit. * 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. * Age \>18 years of age. Because no dosing or adverse event data are currently available on the use of KK-LC-1 T cell receptor (TCR) in participants \<18 years of age, children are excluded from this study. * Eastern Cooperative Oncology Group (ECOG) performance status \<1. * Participants must have adequate organ and marrow function as defined below: * leukocytes \>=3,000/mcL * absolute neutrophil count \>=1,500/mcL * platelets \>=100,000/mcL * hemoglobin \>=9.0 g/dL * total bilirubin within normal institutional limits * Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) =\<2.5 X institutional upper limit of normal * creatinine within normal institutional limits OR * creatinine clearance \>=60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal. -Serology: * Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who are HIV seropositive can have decreased immune-competence and thus are less responsive to the experimental treatment and more susceptible to its toxicities.) * Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the participant must be tested for the presence of antigen by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative. * The effects of the study agent on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, individuals of child-bearing potential and their partners must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and up to twelve (12) months after treatment. Individuals of childbearing potential must have a negative pregnancy test. Individuals of childbearing potential are defined as all individuals except individuals who are postmenopausal or who have had a hysterectomy. Postmenopausal will be defined as individuals over the age of 55 who have not had a menstrual period in at least one year or a participant that has received a treatment (i.e., chemotherapy or pelvic radiation) that has resulted in them becoming postmenopausal. Should an individual become pregnant or suspect pregnancy while individuals or partner is participating in this study, individuals should inform treating physician immediately. * Because there is a potential risk for adverse events in nursing infant's secondary to treatment of the mother with KK-LC-1 TCR transduced peripheral blood lymphocytes (PBLs), breastfeeding should be discontinued if the mother is treated with KK-LC-1 TCR transduced PBL. These potential risks may also apply to other agents used in this study. * More than four weeks must have elapsed since any prior systemic therapy at the time the participant receives the KK-LC-1 TCR T cells. * Participants may have undergone minor surgical procedures within the past three weeks, as long as all toxicities have recovered to Grade 1 or less * Ability of subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Participants who are receiving any other investigational agents. * History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine or aldesleukin. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Participants with abnormal pulmonary function tests but stable obstructive or restrictive pulmonary disease may be eligible. * Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). * Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). * Participants with autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis or pancreatitis, and systemic lupus rythematosus. Hypothyroidism, vitiligo and other minor autoimmune disorders are not exclusionary. * Participants on active systemic immunosuppressive therapy that cannot be safely withheld. * Participants with a history of coronary revascularization or ischemic symptoms unless participant has a normal cardiac stress test. * Any condition which would, in the opinion of the Principal Investigator, indicate that the subject is a poor candidate for the clinical trial or would jeopardize the subject or the integrity of the data obtained. * Documented left ventricular ejection fraction (LVEF) \<= 45%
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States