Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether CC-38, a treatment made from a patient’s own tumour-infiltrating lymphocytes (TILs) expanded outside the body, can be given repeatedly to people with metastatic colorectal or prostate cancer. They expect repeated infusions, alongside pembrolizumab and immune-supporting treatment, might help TILs persist in the blood and increase their chance of entering tumours.
The idea is that longer-lasting, tumour-targeting immune cells could improve the immune system’s access to cancer cells, but this trial is mainly measuring whether repeated CC-38 treatment is safe, tolerated and feasible—not whether it helps people live longer or delays cancer growth.
Worth knowing: This is a small, non-randomised early-phase trial of 12 people with no comparison group, so it cannot establish whether the treatment is better than standard care.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07255664 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 12 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | CuraCell TX AB |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug CC-38
- Drug Pembrolizumab
- Drug Cyclophosphamid
- Drug Interleukin-2
- Drug Uromitexan
What it is measuring
Evaluation of safety, tolerability, and feasibility of repeated administrations of the novel ATIMP, CC-38.
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- 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)
- 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 sur…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: Germany.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07255664, registered by CuraCell TX AB on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.