Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07255664
A FIH, Phase I/IIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC
Led by Curacell Holding AB · Updated on 2025-12-08
12
Participants Needed
1
Research Sites
176 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
This is a First-In-Human trial investigating a novel expansion protocol of an ATIMP (CC-38), composed of autologous TIL.
CONDITIONS
Official 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 trial procedures
- Patient is 18 years or older at consent
- Patient lives within 50 km of a hospital for care
- Histological or cytological confirmation of stage IV colorectal cancer (any T / any N / M1) not suitable for curative surgery OR stage III locally advanced or stage IV metastatic prostate cancer
- Patient has received all standard therapies according to guidelines and local practice, with insufficient response, medical contraindication, or refusal
- Confirmed disease progression by radiologic imaging after prior therapy
- Sufficient quality tumor tissue not previously irradiated available for TIL harvest via surgery or consented biopsy
- At least one measurable or assessable lesion remaining after tumor resection for CC-38 manufacturing
- ECOG performance status of 0 or 1
- Minimum life expectancy of 6 months as judged by investigator
- Adequate bone marrow, liver, and kidney function as judged by investigator with specified laboratory values
- Female patients are post-menopausal or use effective contraception with failure rate <1% for 6 months after last CC-38 dose
- Male patients with fertile partners agree to condom use with spermicide and partner contraception with failure rate <1% for same period
- Successful tumor tissue sampling with TIL presence confirmed pathologically
- Successful TIL expansion producing final CC-38 drug product
You will not qualify if you...
- Congestive heart failure NYHA class III or IV
- Myocardial infarction or coronary artery bypass graft within 6 months prior to enrollment
- History of significant ventricular arrhythmia or unexplained syncope not due to dehydration or vasovagal causes
- History of severe non-ischemic cardiomyopathy
- Uncontrolled blood pressure (systolic >160 mmHg or diastolic >100 mmHg) within 3 months prior to enrollment
- Left ventricular ejection fraction below 45%
- Clinically significant cardiovascular events within 6 months before enrollment including unstable angina, angioplasty, stroke, or TIA
- Other health conditions that may risk patient safety during trial participation
- Pulmonary conditions including FEV1 <60%, active obstructive chronic pulmonary disease, oxygen dependence, or increased anesthesiologic risk
- Current or history of central nervous system metastatic disease, leptomeningeal disease, or cord compression
- Untreated or incompletely treated upper GI ulcers or high-risk esophageal varices
- Need for therapeutic anticoagulation or increased bleeding risk
- Severe acute or chronic medical conditions increasing risk or interfering with trial results
- Primary immunodeficiency diseases such as SCID or AIDS
- Active or history of autoimmune or inflammatory disorders unless assessed safe by investigators
- Use of immunosuppressive medications above 10 mg prednisone daily equivalent, except topical or inhaled steroids
- Prior organ or allogenic stem cell transplant
- Known infection with hepatitis B or C, HIV, or syphilis
- Known bone marrow aplasia
- Chronic urinary tract infection or acute urothelial toxicity from prior therapies
- Pregnancy, breastfeeding, or planning pregnancy within specified timeframes
- Inability to comply with trial procedures
- Systemic cancer treatment within 4 weeks prior to enrollment
- Recent palliative radiotherapy or minor surgery within specified intervals
- Unresolved adverse events from previous treatments above grade 1
- Participation in other interventional clinical trials or investigational treatments within 4 weeks
- Bone metastasis only
- Known allergy to any trial regimen component
- For colorectal cancer, presence of BRAF-V600 positive mutation
- Any contraindications to pembrolizumab or auxiliary medicinal products as per current guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
Krankenhaus Nordwest
Frankfurt, Germany, 60488
Actively Recruiting
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Research Team
D
Dragan Kiselicki, Dr.
CONTACT
S
Sabine Beck, Dr.
CONTACT
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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