Trial evaluating safety and efficacy of intratumorally administered inflammatory allogeneic dendritic cells (ilixadencel) in
advanced gastrointestinal stromal tumors

Tumour shrinking with DCT

Tumour shrinking with DCT



Patients with advanced gastrointestinal stromal tumor (GIST) develop resistance to imatinib, and subsequent treatments have limited efficacy. Ilixadencel (allogeneic inflammatory dendritic cells) is a cell-based immune primer injected intratumorally that previously has been clinically investigated in metastatic renal cell carcinoma and hepatocellular carcinoma. As a result the Ilixadencel treatment presented an acceptable safety profile among advanced GIST patients with encouraging radiological tumor responses.


The study involved 6 patients, men and women, age 46 years old to 82 years old with the median age of 47 years old, with a diagnosis of unresectable or metastatic GIST that had progressed despite second-, third-, or fourth-line treatment with a TKI were enrolled in this trial.

Adequate bone marrow, liver and renal function and with no viral disease like Hepa B, C and HIV.


Ilixadencel was prepared from healthy blood donors. Cells in the leukapheresis and thereafter fractionated by elutriation in a close system, ELUTRA®. The elutriation results in a cell product in fraction 5 that contains > 90% CD14+ monocytes. These cells are used for differentiation (using the well-established differentiation cocktail GM-CSF plus IL-4) and activation (R848.poly-IC and IFN-gamma) into proinflammatory DCs.

The final drug product is cryopreserved cells formulated in human plasma and 10% DMSO. Immediately before administration to the patient, the frozen vials were thawed, and the cells were washed and resuspended in 0.15 M saline with 2% human serum albumin before administration. These cells were used as a direct-injectable product after thawing without any additional preparation steps prior to the intratumorally administration.


DC vaccine doses of 5 × 106 (low dose), 10 × 106 (medium dose), and 20 × 106 (high dose) were used and administered intratumorally (IT). All patients received a dose of 10×106.


During the trial, five out of six patients experienced a total of 19 AEs. Grade 1 was the most common with 10 AE reported in 4 patients (66.7% of total); 8 grade 2 in 2 patients (33.3%), and 1 patient with grade 3 (16.7%). The adverse events related to ilixadencel, as defined by probable or possibly causative of ilixadencel, were 6 AEs. The AEs related to ilixadencel treatment was fever and chills (50%), abdominal pain (33%), and discomfort at injection site (17%). The grade 3 AE was related to general health deterioration and not related to ilixadencel treatment. No clinically relevant abnormalities were noted post-treatment with regard to hematology, biochemistry, coagulation, or serology.

Tumor response:
3 patients showed tumor progression at 3 months per RECIST. 1 patient showed clinical deterioration and CT scan was per- formed after 2 months, which showed progressive disease. One patient (on third line regorafenib) had stable disease for 9 months and another patient (on second line sunitinib) had stable disease at end of study (12 months) as per RECIST 1,1. These two patients developed a partial response as per Choi criteria with a duration of 3 and 6 months, respectively. The median PFS for the trial cohort was 4.0 months (95%; CI 3.2–4.8); the median OS was 19.0 months (95% CI 11.8–26.2).


Ilixadencel treatment presented an acceptable safety profile among advanced GIST patients who developed resistance to TKI. Encouraging radiological tumor responses were detected in 33% of treated patients.

Article Reference link: click here

Scientific article publishing date : 28/5/2020

Immucura identifier : BSC21_023EN