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CYNK-101 + Trastuzumab + Pembrolizumab for Gastroesophageal Cancer
Study Summary
This trial will study the safety and effectiveness of a new cancer treatment that uses NK cells, which are derived from human placental CD34+ cells, to treat patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma that has spread and cannot be removed with surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have not received a live vaccine in the last 28 days.I needed treatment for fluid buildup in my chest or abdomen recently.I have an immune system disorder or am taking more than 10 mg of steroids like prednisone daily.I have been treated for an autoimmune disease in the last 2 years.I have HER2-positive advanced stomach or junction cancer confirmed by tests.My gastric cancer's HER2 status was checked with an FDA-approved test.I received radiotherapy less than 14 days before my second visit.I am 18 years old or older.My cancer shows high levels of HER2 according to specific tests.I have an active tuberculosis infection.My cancer tests show a high level of HER2 protein or positive HER2 gene test.My heart is strong, with a good ejection fraction and normal QT interval.I have or had lung inflammation treated with steroids.I am currently being treated for an infection.I do not have an active infection like hepatitis or COVID-19 needing treatment.I will undergo a biopsy to confirm HER2 expression before joining the study.I haven't had major surgery or serious injury in the last 28 days and don't expect to need major surgery during the study.I am fully active or restricted in physically strenuous activity but can do light work.I have had treatment for cancer that could not be surgically removed or has spread.I have a heart condition that affects my daily life.I have another cancer besides the one being studied, but it hasn't needed treatment in the last 3 years.I have mild to severe nerve damage.I have brain metastases that are untreated or getting worse.I am not allergic to pembrolizumab, trastuzumab, certain chemotherapies, rhIL-2, murine proteins, or platinum products.I had additional cancer treatment over a year ago.I have received an organ or tissue transplant from another person.My blood, kidney, liver, and clotting tests are within normal ranges.
- Group 1: Phase IIa Expansion
- Group 2: Phase I Dose Escalation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this clinical investigation open to participants aged 30 and above?
"The requirements to be included in this medical trial stipulate that participants must have a minimum age of 18 and cannot exceed 75 years old."
What are the expected outcomes of this experimental protocol?
"The primary measure of success for this trial is Dose-Limiting Toxicity (DLT) over a period up to 12 months. Secondary parameters which need to be assessed include Incidence of Response conversion post CYNK-101 infusion, Overall Survival (OS), and incidence of Treatment Emergent adverse events (TEAE)."
Are there any available vacancies in this research endeavor?
"Data hosted on clinicaltrials.gov indicates that this research endeavour is still recruiting patients, with the trial having been first put up for advertisement on April 14th 2022 and last updated September 29th of the same year."
How many participants are presently involved in this experiment?
"This clinical trial necessitates 52 participants that meet the outlined criteria. Eligible patients can be recruited from centres such as Scripps Health in La Jolla, California or John Theurer Cancer Center at Hackensack University Medical Center in Hackensack, New jersey."
Who qualifies to join this medical research endeavor?
"This clinical trial seeks 52 participants aged 18 to 75 who have been diagnosed with adenocarcinoma. In order for a patient's application to be accepted, they must meet the following conditions: having reached the age of majority on signing informed consent; their cancer being cytologically or histologically confirmed as unresectable/metastatic HER2-positive gastric or gastroesophageal junction (G/GEJ); and finishing adjuvant therapy more than 12 months prior to visit two. Moreover, those who had an INDUCTION regimen prior to study entry but achieved either stable disease per RECIST after 6 cycles or"
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