Metastatic Colorectal CancerPhase 1/2ProbeTILityNCT07255664
A FIH, Phase I/IIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC
A Phase 1/2 study testing CC-38, Pembrolizumab and Cyclophosphamid in people with Metastatic Colorectal Cancer and Prostate Cancer Metastatic, run by CuraCell TX AB at 1 site in Germany.
Trial summary
This is a First-In-Human trial investigating a novel expansion protocol of an ATIMP (CC-38), composed of autologous TIL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Prostate Cancer Metastatic, Prostate Cancer Locally Advanced
- What is being tested?
- CC-38, Pembrolizumab and Cyclophosphamid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 13 Nov 2025to Apr 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient (female or male) has signed informed consent according to ICH/GCP and national/local 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 in an area where a hospital for care can be reached within a maximum of 50 km.
- Patient has histological or cytological confirmation of:
- colorectal cancer, which is stage IV (any T / any N / M1), not amenable to curative surgery, OR
- prostate cancer, which is stage III locally advanced, not amenable to curative surgery (T3-4 / N0 / M0 or any T / N1 / M0), or stage IV metastatic (any T / any N / M1)
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- Patient has received all lines of therapy that
- are considered SOC for the patient's indication according to applicable European/national professional society medical guidelines and local medical practice at time of enrollment
- are available via the national health insurance system and the patient is considered eligible for but led to insufficient response or were medically not justified or refused by the patient.
- Patient has confirmed disease progression by radiologic imaging from the previous line of therapy.
- Patient has sufficient amount of previously not irradiated tumor tissue in adequate quality for TIL harvest and expansion, i.e., either:
- Primary or metastatic lesion has been selected for surgery (e.g., to reduce tumor burden, pain relief), Or
- Patient has consented to surgery for the purpose of tissue harvesting for TIL expansion and is considered suitable to undergo surgery for this purpose. Note: Patients with a non-justifiable anesthesiologic and/or surgical risk, as determined by the investigator, should be excluded
- Patient has a least one measurable or assessable lesion according to RECIST 1.1 remaining after tumor resection for CC-38 manufacturing has been performed.
- Patient has ECOG performance status of 0 or 1.
- Patient has a minimum life expectancy of 6 months in the opinion of the investigator from the time of consent date.
- Patient has adequate bone marrow, hepatic and renal function in the opinion of the investigator:
- Hemoglobin ≥ 9.0 g/dL,
- Absolute neutrophil count (ANC) ≥ 1.0 x 109 /L,
- Platelets ≥ 80 x 109 /L,
- Calculated creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula),
- Serum bilirubin ≤ 1.5 x ULN (or ≤ 2.5 x ULN in the presence of documented Gilbert's Syndrome [unconjugated hyperbilirubinemia] or liver metastases),
- AST/ ALT and alkaline phosphatase ≤ 2.5 x ULN (or ≤5 times ULN in the presence of bone and/or liver metastases), ALP ≤ 2.5 x ULN,
- International normalized ration (INR) ≤ 1.5 or prothrombin time (PT) ≤ ULN + 4 seconds.
- Female patients must be post-menopausal or use contraceptive methods with a failure rate of < 1% 6 months after last administration of CC-38, whatever is later, to prevent pregnancy. Male patients with fertile female partners must be willing to use condoms with spermicide, and the fertile partner must use contraceptive methods with a failure rate of < 1% for the same time period. Male patients must also refrain from donating sperm for the same time period.
- Successful tumor tissue sampling by surgery, including presence of TILs in the tumor tissue in the pathological evaluation.
- Successful TIL expansion defined as obtaining the final CC-38 drug product
Who cannot join
- Patient as any of the following condition:
- Congestive heart failure NYHA class III or IV,
- myocardial infarction or coronary artery bypass graft within 6 months prior to enrollment,
- history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration,
- history of severe non-ischemic cardiomyopathy,
- uncontrolled blood pressure as defined as systolic > 160 mmHg, diastolic > 100 mmHg within 3 months prior to enrollment,
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- left ventricular ejection fraction (LVEF) < 45% as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan,
- any other clinically significant cardiovascular events such as unstable angina, angioplasty, stroke, or transient ischemic attack (TIA) within less than 6 months before enrolment,
- other conditions that the treating physicians believe may endanger the health of the patients by their participation in this clinical trial.
- Patient has any of the following pulmonary conditions:
- Forced expiratory volume in 1 second (FEV1)<60%,
- Active obstructive chronic pulmonary disease,
- oxygen dependence as defined by a blood oxygen saturation that can only be maintained above 92% by oxygen inhalation (finger oxygen detection method),
- other pulmonary conditions that increase the anesthesiologic risk.
- Patient has a current or history of central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression,
- Patient has ulcers in the upper GI tract, untreated or incompletely treated esophageal varices with high risk of bleeding in the investigator's discretion.
- Patient requiring therapeutic anticoagulant therapy or having other increased risk of bleeding events.
- Patient has any severe acute or chronic medical condition that places the patient at increased risk or interferes with the interpretation of trial results in the opinion of the investigator.
- Patient has any form of primary immunodeficiency (such as severe combined immunodeficiency disease [SCID] and acquired immune deficiency syndrome [AIDS]).
- Patient has active or history of autoimmune or inflammatory disorders. Note: Patients may be eligible if they have been assessed in discussion between Principal Investigator, Chief Medical Officer and Senior Medical Consultant as not posing an increased risk to the patient.
- Patient receiving immunosuppressive concomitant medications (≥ 10 mg prednisone daily or other equivalent). Steroid medications are allowed if they are used as substitution or are administrated topically or as inhalations.
- Patient has received an organ and/or allogenic stem cell transplant.
- Patient has known acute or chronic infection with hepatitis B or C virus.
- Patient has known HIV infection (seropositive for HIV antibody).
- Patient has known infection with syphilis.
- Patient has known bone-marrow aplasia.
- Patient has known (chronical) urinary tract infection and/ or acute urothelial toxicity from previous cytotoxic chemotherapy or radiation therapy or urinary flow obstructions.
- Female patient, who is pregnant or breast-feeding, or plan to become pregnant within 12 months after cyclophosphamide or 6 months after last dose of CC-38, whichever last. Women of childbearing potential must have a negative pregnancy test at screening and before every CC-38 application.
- Patient is unable to comply with trial procedures, restrictions, or requirements.
- Patient received last previous systemic cancer treatment (including anti-testosterone treatment) within less than 4 weeks prior enrollment.
- Note: Bridging therapies (specified in trial design [section 2 - subsection: screening and TIL harvesting]) after TIL harvesting and before CC-38 administration are permitted after consultation between Principal Investigator, Chief Medical Officer and Senior Medical Consultant.
- Patient received last palliative radiotherapy within less than 4 weeks prior enrollment - where RECIST 1.1 evaluable metastases are within the radiation area.
- Patient received minor surgery (as judged by the investigator, i.e., port implantation) within less than 3 weeks prior enrollment.
- Patient with AEs from previous treatment that have not recovered to CTCAE v5.0 ≤ grade 1 Note: Clinically insignificant grade 2 AEs that may be allowable if discussed between and approved by Principal Investigator, Chief Medical Officer and Senior Medical Consultant.
- Patient participates in any other interventional clinical trial or has been treated with any investigational research products within 4 weeks prior to the initiation of screening.
- Patient has bone metastasis only.
- Patient has known hypersensitivity to any component of the trial regimen.
- For colorectal cancer: Patient has been diagnosed with histologically or cytologically proven BRAF-V600 positive CRC.
- Patient has any further contraindication to the IMP pembrolizumab or any of the auxiliary medicinal products (i.e., IL-2, cyclophosphamide, uromitexan) as per current EU SmPCs to the respective product.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Krankenhaus Nordwest
Frankfurt, 60488
Dragan Kiselicki, Dr.
About this study
Official title: A FIH, 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
This is a First-In-Human trial investigating a novel expansion protocol of an ATIMP (CC-38), composed of autologous TIL.
Read the detailed description
T-cell therapies have demonstrated successful responses in solid tumors, most frequently studied in malignant melanomas. In the present trial, we include patients with metastatic colorectal cancer and metastatic prostate cancer, two cancer forms that have not been well studied in T-cell therapy studies, yet.
In the ProbeTILity trial we hypothesize that in patients with metastatic CRC or metastatic prostate cancer ex vivo expansion of repeated re-administration of TIL establishes a more long-term persistence of TILS in the patient´s blood stream, that could increase the likelihood of tumor infiltration by TILs.
- Conditions
- Metastatic Colorectal Cancer, Prostate Cancer Metastatic, Prostate Cancer Locally Advanced
- Being tested
- CC-38, Pembrolizumab, Cyclophosphamid, Interleukin-2, Uromitexan
- Keywords
- mCRC, aPC, TIL, Immunotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-38Drug
CC-38 drug product is an autologous ATIMP composed of in vitro expanded tumor-infiltrating T-lymphocytes.
PembrolizumabDrug
Also called Keytruda
A concomitant IMP is pembrolizumab
CyclophosphamidDrug
Cyclophosphamid is used as a AxMP
Interleukin-2Drug
Also called Proleukin S
Interleukin-2 is used as a AxMP.
UromitexanDrug
Uromitexan is used as a AxMP.
| Study group | Role | What they receive |
|---|---|---|
| CC-38 Drug Product | Experimental | The advanced therapy investigational medicinal product (ATIMP) of this trial is an autologous tumor infiltrating lymphocytes (TIL)/ personalized TIL administration (product name CC-38). Receives: Drug: CC-38; Drug: Pembrolizumab; Drug: Cyclophosphamid; Drug: Interleukin-2; Drug: Uromitexan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety, tolerability, and feasibility of repeated administrations of the novel ATIMP, CC-38.
Incidence of treatment-emerged adverse events (TEAE) and the occurrence of severity grade 3 or higher adverse events according to NCI CTCAE v. 5.0; proportion of patient receiving at least two CC-38 administrations without TEAEs preventing CC-38 administrations
Measured: 42 months
Secondary outcomes (1)
Evaluation of efficacy of repeated administrations of the novel ATIMP CC-38 in patients
Measurable objective response rate: Proportion of patients with complete [CR] or partial response [PR] as best response to treatment within the first 6 months after start of CC-38 administration (RECIST 1.1/iRECIST), or death from any cause, whichever comes first.
Progression-free survival: time from start of treatment to time of disease progression (RECIST 1.1/ iRECIST), or death from any cause, whichever comes first.
Time to tumor progression: time from start of treatment to disease progression (RECIST 1.1/iRECIST) Overall survival (OS): time from start of treatment to time of death from any cause.
For prostate cancer cohort: Patient individual changes in prostate-specific antigen levels from baseline until 6 months after start of treatment.
For colorectal cancer cohort: Patient individual changes in carcinoembryonic antigen and cancer antigen 19-9 levels from baseline until 6 months after start of treatment.
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start13 Nov 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CuraCell TX AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zellwerk GmbH, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, Krebsforschung Rhein-Main e.V.
- Responsible party
- Sponsor
- Investigators
- Torbjörn Strom, Study chair, CuraCell TX AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255664
- Sponsor's protocol ID
- CuraCell-Ger-01
- Other IDs
- 2025-521227-70-00, 2025
- Acronym
- ProbeTILity
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A FIH, 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
- ClinicalTrials.gov ID
- NCT07255664
- Acronym / sponsor ID
- ProbeTILity / CuraCell-Ger-01
- Conditions
- Metastatic Colorectal Cancer, Prostate Cancer Metastatic, Prostate Cancer Locally Advanced
- Keywords
- mCRC, aPC, TIL, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- CuraCell TX ABIndustry (pharma, biotech, devices)
- Collaborators
- Zellwerk GmbH, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, Krebsforschung Rhein-Main e.V.
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a First-In-Human trial investigating a novel expansion protocol of an ATIMP (CC-38), composed of autologous TIL.
Detailed description
T-cell therapies have demonstrated successful responses in solid tumors, most frequently studied in malignant melanomas. In the present trial, we include patients with metastatic colorectal cancer and metastatic prostate cancer, two cancer forms that have not been well studied in T-cell therapy studies, yet.
In the ProbeTILity trial we hypothesize that in patients with metastatic CRC or metastatic prostate cancer ex vivo expansion of repeated re-administration of TIL establishes a more long-term persistence of TILS in the patient´s blood stream, that could increase the likelihood of tumor infiltration by TILs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CC-38 Drug Product | Experimental | Drug: CC-38, Drug: Pembrolizumab, Drug: Cyclophosphamid, Drug: Interleukin-2, Drug: UromitexanThe advanced therapy investigational medicinal product (ATIMP) of this trial is an autologous tumor infiltrating lymphocytes (TIL)/ personalized TIL administration (product name CC-38). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Patient (female or male) has signed informed consent according to ICH/GCP and national/local 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 in an area where a hospital for care can be reached within a maximum of 50 km.
- Patient has histological or cytological confirmation of:
- Patient has received all lines of therapy that
Key exclusion criteria (39 listed)
- Patient as any of the following condition:
- Patient has any of the following pulmonary conditions:
- Patient has a current or history of central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression,
- Patient has ulcers in the upper GI tract, untreated or incompletely treated esophageal varices with high risk of bleeding in the investigator's discretion.
- Patient requiring therapeutic anticoagulant therapy or having other increased risk of bleeding events.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-38CC-38 drug product is an autologous ATIMP composed of in vitro expanded tumor-infiltrating T-lymphocytes. | Drug | CC-38 Drug Product |
| PembrolizumabAlso: KeytrudaA concomitant IMP is pembrolizumab | Drug | CC-38 Drug Product |
| CyclophosphamidCyclophosphamid is used as a AxMP | Drug | CC-38 Drug Product |
| Interleukin-2Also: Proleukin SInterleukin-2 is used as a AxMP. | Drug | CC-38 Drug Product |
| UromitexanUromitexan is used as a AxMP. | Drug | CC-38 Drug Product |
Primary outcome
Evaluation of safety, tolerability, and feasibility of repeated administrations of the novel ATIMP, CC-38.
Time frame: 42 months
Incidence of treatment-emerged adverse events (TEAE) and the occurrence of severity grade 3 or higher adverse events according to NCI CTCAE v. 5.0; proportion of patient receiving at least two CC-38 administrations without TEAEs preventing CC-38 administrations
1 secondary outcome
Evaluation of efficacy of repeated administrations of the novel ATIMP CC-38 in patients
Time frame: 42 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Torbjörn Strom study chair
CuraCell TX AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CC-38, Pembrolizumab and Cyclophosphamid in people with Metastatic Colorectal Cancer and Prostate Cancer Metastatic, run by CuraCell TX AB at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dragan Kiselicki, Dr. (0069 7601 4420, probetility@ikf-khnw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of safety, tolerability, and feasibility of repeated administrations of the novel ATIMP, CC-38. (time frame: 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.