KEY TAKEAWAYS
- The phase I/II Allocetra-OTS trial aimed to evaluate the safety and effectiveness of Allocetra delivered by pressurized intraperitoneal aerosol in combination with PIPAC.
- The study used a dose-escalation design to find the optimal safe and effective dose.
- The study’s initial results showed that Allocetra cellular therapy was safe.
Novel intraperitoneal delivery systems like PIPAC can improve the treatment of peritoneal carcinomatosis, but survival rates are still low. Allocetra, an immunomodulatory cellular therapy, shows promise in preclinical studies. Researchers aimed to evaluate the safety and effectiveness of Allocetra delivered by pressurized intraperitoneal aerosol in combination with PIPAC.
Allocetra is derived from healthy donors’ mononuclear cells induced into early apoptosis. Its safety for intraperitoneal administration via a pressurized aerosol system (Capnopen, Capnomed, Germany) was assessed in a dose-finding safety study for advanced peritoneal cancer patients ineligible for Cytoreductive Surgery (CRS) with Hyperthermic Intraperitoneal Chemotherapy (HIPEC). The study involved two cohorts of 3 pts each, who received escalating Allocetra doses every 6 weeks, followed by two cohorts of three patients each to evaluate the sequencing of Allocetra and PIPAC.
The study showed stable and acceptable cellular characteristics, recovery, and potency. In the first cohort (n=3), pts received escalating Allocetra doses of 1 x 109, 2.5 x 109, and 5 x 109 cells, followed by PIPAC. These pts had advanced colon and appendicular carcinomas with prior treatments. They were monitored for a median of 15 weeks (range 7-32) for adverse events. Adverse events (AEs) included mild, common post-surgical issues such as abdominal pain, surgical wound pain, and shoulder pain. None were attributed to Allocetra. All pts were alive and under continued observation.
The study’s initial results demonstrated that Allocetra cellular therapy was safe when administered via pressurized intra-peritoneal aerosol. More pts will be treated with increasing doses of Allocetra to assess its safety and effectiveness.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.e14537
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT05431907
Almog Ben-Yaacov, Mohammad Adileh, Oren Hershkovitz, Einat Galamidi, Veronique Amor, Lior Binder, Dror Mevorach, and Aviram Nissan. DOI:10.1200/JCO.2023.41.16_suppl.e14537 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) e14537-e14537.
