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A plain-language summary of the goals, design and what participants do
This clinical trial is studying a novel immunotherapy treatment for patients with metastatic colorectal cancer or locally advanced or metastatic prostate cancer. The treatment being studied is called CC-38, which is a type of therapy that uses the patient's own tumor-infiltrating lymphocytes (immune cells that naturally penetrate tumors). The purpose of this study is to evaluate the safety, tolerability, and feasibility of giving multiple doses of this treatment to patients whose disease has continued to progress despite previous treatments.
The trial is a first-in-human study, meaning this treatment has not been tested in people before. It involves taking a sample of the patient's tumor tissue through surgery, extracting the tumor-infiltrating lymphocytes, growing them in a laboratory to increase their numbers, and then returning these cells to the patient as a form of treatment. Patients will receive multiple administrations of the CC-38 treatment over the course of the study.
To participate, patients must have colorectal cancer that has spread to other parts of the body (stage IV) or prostate cancer that is either locally advanced (stage III) or has spread to other parts of the body (stage IV). Their disease must have progressed despite previous standard treatments, and they must have measurable disease remaining after the tumor sample is taken for creating the treatment.
The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.
19 criteria
10 criteria
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A malignancy that develops in the prostate gland, a small walnut-shaped gland in men that produces seminal fluid. In locally advanced stages, the cancer has grown outside the prostate but has not yet spread to distant organs. When metastatic, the cancer cells have spread beyond the prostate to other parts of the body, commonly to bones and lymph nodes. The disease typically progresses slowly in early stages, but advanced disease may grow more rapidly and cause symptoms such as difficulty urinating, blood in urine, pelvic discomfort, and bone pain in cases of bone metastases.
A cancer that starts in the colon or rectum, parts of the large intestine. Metastatic colorectal cancer means the cancer has spread from its original site to distant organs, most commonly the liver and lungs. The disease usually begins as small, noncancerous (benign) clumps of cells called polyps that form on the inside of the colon and can develop into cancers over time. As it progresses, patients may experience persistent changes in bowel habits, rectal bleeding, abdominal discomfort, fatigue, and unexplained weight loss.
Other trials in this disease – keep exploring while you decide
Austria
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