Is NCT05483491 recruiting in New Brunswick, NJ?

Yes, NCT05483491 is currently recruiting participants at its New Brunswick, NJ location. This gastric cancer clinical trial is actively enrolling qualified participants.

How do I join the gastric cancer clinical trial in New Brunswick?

To join this clinical trial in New Brunswick, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New Brunswick clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Gastric Cancer Clinical Trial in New Brunswick, NJ

About This Gastric Cancer Study in New Brunswick

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. The safety profile and clinical response to treatment will be determined.

Sponsor: Christian Hinrichs

Who Can Participate

Inclusion Criteria

Subjects 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 IHC test will be performed by the Rutgers Cancer Institute, Department of Biorepository Services.

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 unsuitable for standard therapy.

Subjects 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 before protocol treatment. Patients with surgically resected brain metastases are eligible.

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 for 12 months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.

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. Subjects on anticoagulant therapy must have a PT or PTT within therapeutic range and no history of severe hemorrhage.

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 Version 5.0 or have demonstrated clinical stability and meet the eligibility criteria for the protocol.

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. Note: Patients may have undergone minor surgical procedures within the past three weeks, as long as all toxicities have recovered to Grade 1 or less.

Exclusion Criteria

Subjects 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 would limit compliance with study requirements.

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 KK-LC-1 TCR cells. The potential risks may also apply to other agents used in this study.

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 evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.

Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).

Subjects 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 eligible. Prior history of potentially severe autoimmune diseases without a current, active diagnosis is not exclusionary. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.

Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:

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.

Subjects 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Brunswick?

Yes, this clinical trial (NCT05483491) has an active research site in New Brunswick, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Gastric Cancer Treatment Options in New Brunswick, NJ

If you're searching for gastric cancer treatment options in New Brunswick, NJ, this clinical trial (NCT05483491) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Brunswick research site is actively enrolling participants for this clinical trial. You'll receive care from experienced gastric cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all gastric cancer clinical trials near you to find additional studies recruiting in your area.

Gastric Cancer Clinical Trial in New Brunswick, NJ

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