What is CC-38 studying for metastatic colorectal and prostate cancer?

CC-38 is being studied as a new personalized immunotherapy made from a patient's own tumor-infiltrating lymphocytes. This trial evaluates whether repeated doses of CC-38 can safely and feasibly treat metastatic colorectal and prostate cancers by potentially improving immune cell presence in tumors. The research is sponsored by CuraCell TX AB and aims to better understand this treatment's role in these cancers.

Who may be eligible for this metastatic colorectal or prostate cancer clinical trial?

Adults 18 years or older with confirmed metastatic colorectal or locally advanced/metastatic prostate cancer may be eligible. Participants must have disease progression after standard therapies and be able to access a hospital within 50 km. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic colorectal or prostate cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for their own transportation and related costs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID07255664

First-in-Human Phase IIIa Trial Testing Safety and Feasibility of Repeated Autologous TIL Immunotherapy in Patients With Metastatic Colorectal or Prostate Cancer

Led by CuraCell TX AB · Updated on 2026-06-22

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating a novel autologous T-cell therapy called CC-38 for patients with metastatic colorectal cancer and metastatic prostate cancer. These cancers have not been extensively studied with T-cell therapies before. The trial aims to evaluate whether repeated administration of this personalized therapy can increase the persistence of tumor-infiltrating lymphocytes TILs in the bloodstream, potentially improving tumor infiltration by these immune cells. The investigational treatment, CC-38, is a personalized therapy made from the patients own tumor-infiltrating lymphocytes expanded in the lab. Patients will receive repeated doses of CC-38 along with supportive medications including pembrolizumab, cyclophosphamide, interleukin-2, and uromitexan. The study is an open-label, single-group trial assessing the safety, tolerability, and feasibility of this novel treatment over an extended period. Participants will be closely monitored throughout the study for safety and treatment effects over 42 months. Assessments include imaging to confirm disease progression, pathological evaluation of tumor tissue, and laboratory tests to evaluate organ function and immune response. The primary outcome is safety and feasibility, while secondary outcomes focus on the treatments efficacy. Follow-up visits and evaluations will track patients health and response to therapy during and after treatment.

CONDITIONS

Brief Title

A FIH, Phase I/IIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patient (female or male) has signed informed consent according to regulations prior to any trial-specific procedure.
Patient is 18 years or older at the time of signing the informed consent form.
Patient must live within 50 km of a hospital for care.
Patient has histological or cytological confirmation of stage IV colorectal cancer not eligible for curative surgery, OR stage III locally advanced or stage IV metastatic prostate cancer not eligible for curative surgery.
Patient has received all standard-of-care therapies available and has insufficient response, medical contraindications, or refusal for further treatment.
Patient shows confirmed disease progression by imaging after previous therapy.
Patient has sufficient non-irradiated tumor tissue for TIL harvest and expansion.
Patient has at least one measurable or assessable lesion after tumor resection for CC-38 manufacturing.
Patient has ECOG performance status of 0 or 1.
Patient has a minimum life expectancy of 6 months.
Patient has adequate bone marrow, liver, and kidney function as defined by specific laboratory criteria.
Female patients must be post-menopausal or use effective contraception; males with fertile partners must use condoms with spermicide and partners must use effective contraception.
Successful tumor tissue sampling and TIL expansion resulting in final CC-38 product.

You will not qualify if you...

Patient has severe cardiovascular conditions including congestive heart failure NYHA III/IV, recent myocardial infarction or bypass surgery, significant arrhythmia, severe cardiomyopathy, uncontrolled high blood pressure, low ejection fraction, or recent serious cardiovascular events.
Patient has pulmonary conditions such as low lung function (FEV1 <60%), active obstructive pulmonary disease, oxygen dependence, or other increased anesthesiologic risks.
Patient has current or history of central nervous system metastases, leptomeningeal disease, or spinal cord compression.
Patient has ulcers in the upper gastrointestinal tract or untreated esophageal varices with high bleeding risk.
Patient requires therapeutic anticoagulation or has increased bleeding risk.
Patient has severe acute or chronic medical conditions that increase risk or interfere with trial results.
Patient has primary immunodeficiency or HIV infection.
Patient has active or history of autoimmune or inflammatory disorders unless assessed safe by investigators.
Patient is on immunosuppressive medications above specified doses, except certain allowed steroids.
Patient has received organ or allogenic stem cell transplant.
Patient has infections including hepatitis B or C, syphilis, or bone marrow aplasia.
Female patients pregnant, breastfeeding, or planning pregnancy within specified time after treatment.
Patient unable to comply with trial procedures.
Patient had recent systemic cancer treatment, radiotherapy, or minor surgery within specified windows.
Patient has unresolved adverse events from previous treatments above grade 1.
Patient participates in other interventional trials or received investigational products recently.
Patient has bone metastasis only.
Patient has known hypersensitivity to trial drugs.
For colorectal cancer, patient has BRAF-V600 positive tumor.
Patient has contraindications to pembrolizumab or auxiliary drugs per product guidelines.

Research Team

Dragan Kiselicki, Dr.

Sabine Beck, Dr.

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First-in-Human Phase IIIa Trial Testing Safety and Feasibility of Repeated Autologous TIL Immunotherapy in Patients With Metastatic Colorectal or Prostate Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria