Safety Study of Tumor-Infiltrating Lymphocyte (TIL) Therapy for Patients with Metastatic Colorectal or Prostate Cancer

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What is this study about?

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.

1 Tumor Tissue Collection

After joining the study, you will undergo surgery to collect tumor tissue. This tissue will be used to grow your tumor-infiltrating lymphocytes (TILs), which are immune cells found in your tumor that can recognize and attack cancer cells.

The surgery will be performed at a hospital facility, and the collected tissue will be evaluated to confirm the presence of TILs.

2 TIL Expansion Period

The tumor tissue collected during surgery will be processed in a laboratory to grow and multiply your TILs. This process creates the treatment called CC-38.

This expansion process takes time, during which you will not need to undergo any study procedures. You will be notified when your TILs have successfully expanded and are ready for treatment.

3 Preconditioning (Lymphodepletion)

Before receiving your TIL treatment, you will receive preconditioning therapy to prepare your body. This involves chemotherapy with cyclophosphamide (Cyclophosphamid HEXAL) to temporarily reduce your existing immune cells, creating space for the new TILs to work.

During this time, you will also receive mesna (Uromitexan tablets 400 mg) to protect your bladder from side effects of cyclophosphamide.

4 TIL Administration

You will receive your CC-38 TIL treatment as an infusion. This contains your own tumor-fighting immune cells that have been multiplied in the laboratory.

The infusion will be administered in a controlled hospital setting with close monitoring for any reactions.

5 Post-TIL Support Therapy

After receiving your TILs, you will be given aldesleukin (Proleukin®) to help the TILs survive and function in your body. This medication helps stimulate your immune system.

You will also receive pembrolizumab (KEYTRUDA 25 mg/mL), an immunotherapy drug that helps prevent your immune system from shutting down the anti-cancer response.

6 Repeated TIL Administrations

This study is designed to provide multiple administrations of TIL therapy. You may receive additional TIL treatments following the same process (preconditioning, TIL infusion, and support therapy).

The study aims to evaluate if multiple TIL treatments can be safely given and how effective they are against your cancer.

7 Monitoring and Follow-up

Throughout the study, you will undergo regular monitoring including blood tests, imaging scans, and physical examinations to assess how your body is responding to treatment.

For prostate cancer patients, changes in PSA (prostate-specific antigen) levels and PSMA PET-CT scans will be used to monitor response.

For colorectal cancer patients, tumor markers such as CEA and CA-19-9 will be monitored to assess treatment response.

8 Study Completion

The study will monitor your progress for at least 6 months after starting treatment to evaluate the safety and effectiveness of the TIL therapy.

After completing the active treatment phase, you will continue to be followed to assess long-term outcomes including survival and cancer progression.

Who Can Join the Study?

You must have locally advanced or metastatic prostate cancer (cancer that has spread beyond the prostate) or metastatic colorectal cancer (cancer of the colon or rectum that has spread to other parts of the body).
Your disease must be progressing (getting worse over time).
You must be willing to sign an informed consent form before any trial procedures begin.
You must have an ECOG performance status of 0 or 1 (this means you must be able to carry out all or most normal activities).
Your doctor must believe you have a life expectancy of at least 6 months.
You must have adequate bone marrow, liver, and kidney function as determined by various blood tests.
If you’re a female who can become pregnant or a male with a fertile female partner, you must use effective contraception methods.
You must be at least 18 years old.
Your weight must be above 50 kg (about 110 pounds).
You must live in an area where a hospital can be reached within 50 km (about 31 miles).
Your cancer must be confirmed by tissue or cell examination.
For colorectal cancer patients: you must have stage IV cancer that cannot be cured with surgery.
For prostate cancer patients: you must have either stage III locally advanced cancer that cannot be cured with surgery, or stage IV metastatic cancer.
You must have received all standard treatments appropriate for your condition.
Your disease must show progression (worsening) on imaging tests since your last treatment.
You must have enough tumor tissue that has not been previously treated with radiation for the study treatment.
You must have at least one measurable or assessable tumor remaining after surgery for the study treatment.
Your tumor tissue must contain TILs (Tumor Infiltrating Lymphocytes, which are a type of immune cell).
The lab must be able to successfully grow enough of your TILs to create the study treatment.

Who Cannot Join the Study?

You cannot participate if you do not have locally advanced or metastatic prostate cancer or metastatic colorectal cancer (cancers that have spread from their original location).
You cannot participate if your disease is not progressing (getting worse over time).
You cannot participate if you have had previous immunotherapy-related adverse events of grade 3 or higher (serious side effects from immune system treatments).
You cannot participate if you have active autoimmune disease requiring systemic treatment (conditions where your immune system attacks your own body that need medication affecting your whole body).
You cannot participate if you have active or chronic infections including HIV, hepatitis B, or hepatitis C.
You cannot participate if you have brain metastases (cancer that has spread to the brain) unless they have been treated and stable for at least 3 months.
You cannot participate if you have other active malignancies (other types of cancer) within the past 3 years.
You cannot participate if you are pregnant or breastfeeding.
You cannot participate if you have severe heart, lung, liver, or kidney disease.
You cannot participate if you have psychiatric conditions that would interfere with study compliance.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Krankenhaus Nordwest GmbH	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.08.2025

Trial locations

Investigated drugs:

Tumor-Infiltrating Lymphocyte (TIL) therapy (CC-38) is a type of immunotherapy that uses your own immune cells to fight cancer. In this treatment, special immune cells called TILs are taken from your tumor, grown in a laboratory to increase their numbers, and then given back to you. These cells are naturally present in your tumor and have the ability to recognize and attack cancer cells. The goal is to boost your immune system’s ability to fight the cancer.

Investigated diseases:

Prostate cancer – 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.

Colorectal cancer – 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.

Trial ID:

2025-521227-70-00

Protocol code:

ProbeTILity

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Safety Study of Tumor-Infiltrating Lymphocyte (TIL) Therapy for Patients with Metastatic Colorectal or Prostate Cancer

What is this study about?

Who Can Join the Study?

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