Table of contents
- Clinical trial overview
- Who the trial is for
- How the study treatment is given
- What the trial wants to learn
- Trial phase and design
- Main endpoints
- Key trial details
Clinical trial overview
One authorised study is investigating Autologous Human Adipose Perivascular Stromal Cells Genetically Modified To Secrete Soluble Tumour Necrosis Factor-Related Apoptosis-Inducing Ligand in people with locally advanced pancreatic cancer, also described as ductal adenocarcinoma of the pancreas that is non-resectable, meaning it cannot be removed by surgery.[1]
The study is testing RR001, a cell-based gene therapy, together with standard chemotherapy based on GEM/Nab-PTX.[1]
Who the trial is for
The target population is patients with locally advanced, non-resectable pancreatic adenocarcinoma.[1]
The source data does not list detailed inclusion or exclusion rules, so the main known participation group is people with this specific pancreatic cancer setting.[1]
How the study treatment is given
RR001 is given by intratumoral injection, which means the treatment is injected directly into the tumor.[1]
The injections are ultrasound-guided, so imaging is used to help place the needle into the tumor more accurately.[1]
The trial combines RR001 with standard chemotherapy drugs listed in the source data as Gemsol and Abraxane.[1]
What the trial wants to learn
The main goal is to study safety of intratumoral RR001 when it is used with standard chemotherapy.[1]
The study also looks at early efficacy, which means whether the treatment shows signs of helping against the cancer.[1]
Another goal is dose finding: the researchers want to identify the maximum tolerated dose (the highest dose that can be given without too many serious side effects) and the recommended phase IIb dose for later research.[1]
Trial phase and design
This is a Phase 1/2 study, so it combines early safety and dose testing with a first look at possible benefit.[1]
The study is open label, which means both the researchers and the participants know what treatment is being given.[1]
It is also non-randomized, meaning participants are not assigned by chance to different treatment groups.[1]
Main endpoints
The primary endpoints are safety of the ultrasound-guided intratumoral injections and finding the MTD and RP2D after three dose levels.[1]
In simple terms, the study is trying to learn how safe the treatment is, how much can be given, and what dose should be used in future studies.[1]
Key trial details
The trial ID is NCT06861452, its status is Authorised, and the planned enrollment is 18 patients.[1]
Because this is a small early-stage study, its main purpose is to build first evidence for safety and dosing rather than to prove long-term benefit.[1]
