Actively Recruiting
A First-In-Human, Phase I/IIa, Open-label Trial Assessing Safety, Tolerability, and Feasibility of Repeated Administrations of a Novel Autologous TIL-based Immunotherapy in Patients With Metastatic Colorectal or Prostate Cancer
Led by Curacell Holding AB · Updated on 2025-12-08
12
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
Curacell Holding AB
Lead Sponsor
Z
Zellwerk GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new immunotherapy treatment using tumor-infiltrating lymphocytes (TIL) for patients with metastatic colorectal cancer or metastatic prostate cancer. This first-in-human trial aims to study the safety, tolerability, and feasibility of repeatedly administering this novel TIL-based therapy called CC-38. The study seeks to improve long-term persistence of TILs in the bloodstream, potentially enhancing tumor infiltration. These cancers have not been extensively studied with T-cell therapies before. The treatment involves an advanced therapy investigational medicinal product (ATIMP) made from a patient's own expanded TILs, referred to as CC-38. Alongside CC-38, patients may receive other drugs including pembrolizumab, cyclophosphamide, interleukin-2, and uromitexan as part of the therapeutic regimen. The study is open-label and includes repeated administrations of this personalized TIL therapy. The trial monitors the treatment's safety and feasibility over a period of 42 months. Participants will be closely monitored throughout the trial with regular assessments including imaging studies to confirm disease progression and measure tumor response. Researchers will evaluate safety, tolerability, and treatment feasibility as primary outcomes, along with efficacy as a secondary outcome. Patients will provide tumor tissue samples for TIL expansion and undergo various clinical and laboratory tests. The total study duration for outcome evaluation is 42 months, ensuring long-term follow-up and safety monitoring.
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
Eligibility Criteria
You may qualify if you...
- Patient (female or male) has signed informed consent prior to any trial-specific procedure.
- Patient is 18 years or older at the time of signing the informed consent form.
- Patient lives in an area where a hospital for care can be reached within a maximum of 50 km.
- Patient has histological or cytological confirmation of stage IV colorectal cancer not amenable to curative surgery, OR stage III locally advanced or stage IV metastatic prostate cancer not amenable to curative surgery.
- Patient has received all standard lines of therapy for their condition with insufficient response or medical justification.
- Patient has confirmed disease progression by radiologic imaging from previous therapy.
- Patient has sufficient previously unirradiated tumor tissue for TIL harvest and expansion, obtained by surgery or consented surgical procedure.
- 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 as judged by the investigator.
- Patient has adequate bone marrow, liver, and kidney function as assessed by specific laboratory criteria.
- Female patients are post-menopausal or use effective contraception; male patients with fertile partners must use condoms with spermicide and partners must use effective contraception for specified periods.
- Successful tumor tissue sampling including presence of TILs.
- Successful TIL expansion defined as obtaining the final CC-38 drug product.
You will not qualify if you...
- Patient has congestive heart failure NYHA class III or IV, recent myocardial infarction or coronary artery bypass surgery, significant arrhythmias, severe cardiomyopathy, uncontrolled blood pressure, low left ventricular ejection fraction, or recent significant cardiovascular events.
- Patient has pulmonary conditions such as low forced expiratory volume, active obstructive pulmonary disease, oxygen dependence, or high anesthesiologic risk.
- Patient has current or history of central nervous system metastatic disease or cord compression.
- Patient has ulcers or high-risk esophageal varices.
- Patient requires therapeutic anticoagulant therapy or has increased bleeding risk.
- Patient has severe acute or chronic medical conditions increasing risk or interfering with trial results.
- Patient has primary immunodeficiency or active/history of autoimmune or inflammatory disorders that increase risk.
- Patient receiving immunosuppressive medications above certain doses.
- Patient has received organ or allogenic stem cell transplant.
- Patient has known infections with hepatitis B, C, HIV, syphilis, or bone marrow aplasia.
- Patient has urinary tract infection or toxicity from previous therapies.
- Female patients who are pregnant, breastfeeding, or planning pregnancy within specified timeframes.
- Patient unable to comply with trial procedures.
- Patient received systemic cancer treatment or palliative radiotherapy within 4 weeks prior to enrollment.
- Patient received minor surgery within 3 weeks prior to enrollment.
- Patient has unresolved adverse events from prior treatments.
- Patient participates in other interventional trials or received investigational products within 4 weeks.
- Patient has bone metastasis only.
- Patient has known hypersensitivity to trial regimen components.
- For colorectal cancer, patient has BRAF-V600 positive tumors.
- Patient has contraindications to pembrolizumab or auxiliary medicinal products as per product guidelines.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 42 months
Participants receive repeated administrations of the novel autologous tumor infiltrating lymphocytes (TIL)-based immunotherapy CC-38 along with concomitant medications including pembrolizumab, cyclophosphamid, interleukin-2, and uromitexan.
Multiple visits for administrations and monitoring during treatment
Duration - Up to 42 months
Participants are monitored for safety, tolerability, and efficacy outcomes after treatment administrations.
Regular visits for assessments following treatment
Trial Site Locations
Total: 1 location
1
Krankenhaus Nordwest
Frankfurt, Germany, 60488
Actively Recruiting
Research Team
D
Dragan Kiselicki, Dr.
S
Sabine Beck, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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