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New treatment option for Gastric Cancer
Official title KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
ClinicalTrials.gov ID: NCT05483491
What this study is testing
What is KK-LC-1 TCR-T cells?
KK-LC-1 TCR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancer.
Also referred to as KK-LC-1 TCR, TIL.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must meet all the following criteria to participate in this study.
- Signed, written informed consent obtained prior to any study procedures.
- Age ≥ 18 years at the time of informed consent.
- Metastatic solid tumor with ≥ 10% of tumor cells positive for KK-LC-1 by IHC assay. Due to the low frequency of KK-LC-1 expression in most cancers...
- HLA-A\ 01:01 allele by HLA haplotype test.
You likely can't join if
- people who meet any of the following criteria will be excluded from participation in this study:
- Current treatment with another investigational agent.
- History of severe allergic reactions to compounds of similar chemical or biologic composition to agents used in study.
- History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.
- Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:
- Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or...
See the full eligibility criteria
Who can join
- people must meet all the following criteria to participate in this study.
- Signed, written informed consent obtained prior to any study procedures.
- Age ≥ 18 years at the time of informed consent.
- Metastatic solid tumor with ≥ 10% of tumor cells positive for KK-LC-1 by IHC assay. Due to the low frequency of KK-LC-1 expression in most cancers, screening will focus on gastric, NSCLC, TNBC, and cervix cancers. The...
- HLA-A\ 01:01 allele by HLA haplotype test.
- Measurable disease per RECIST Criteria Version 1.1 at time of enrollment.
- Prior treatment with cancer type-specific standard of care systemic cancer therapy is required. Standard treatment options must be considered and declined. Documentation of rationale is required if a subject is deemed...
- people with ≤ 3 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...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
- Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.
- Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal/barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and...
- Participants must have 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 except in participants with Gilbert's Syndrome who must have a total bilirubin \< 3.0 mg/dL.
- Serum AST (SGOT)/ALT (SGPT) \< 2.5 x ULN
- Calculated creatinine clearance (CrCl) \> 50 mL/min/1.73 m² for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).
- INR or aPTT ≤ 1.5 X ULN unless the subject is receiving anticoagulant therapy. people on anticoagulant therapy must have a PT or PTT within therapeutic range and no history of severe hemorrhage.
- Serology:
- HIV antibody negative
- Hepatitis B antigen negative
- Hepatitis C antibody negative or HCV RNA negative (i.e., no current HCV infection)
- 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...
- 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...
What rules you out
- people who meet any of the following criteria will be excluded from participation in this study:
- Current treatment with another investigational agent.
- History of severe allergic reactions to compounds of similar chemical or biologic composition to agents used in study.
- History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.
- Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:
- Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or
- Age greater than or equal to 50 years old
- Participants with baseline screening pulse oxygen level of less than or equal to 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated.
- Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that...
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with KK-LC-1 TCR-T cells, breastfeeding should be discontinued if the mother is treated with...
- Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being...
- Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).
- people with HLA-A\ 01:01 damaging mutation or allele loss or other molecular resistance detected by clinical or research genomic profiling will not be eligible.
- Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not...
- Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or how well it works assessments of the investigational regimen are eligible for this trial...
- Carcinoma in situ
- Cutaneous skin cancers requiring only local excision
- Low grade non-muscle invasive bladder cancer
- Low grade prostate cancer Participants with prior or concurrent malignancy that do not meet the above criteria are excluded.
- people who received a live vaccine within 30 days prior to enrollment are not eligible.
- Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.