The novel combined immunotherapy CRX100 has been dosed in the first patient with refractory solid tumors in a phase 1, open-label, dose-escalation study.
The novel combined immunotherapy CRX100 has been dosed in the first patient with refractory solid tumors in a phase 1, open-label, dose-escalation study (NCT04282044), according to a press release from BioEclipse Therapeutics.1
CRX100 was developed with technologies from Stanford University and combines cytokine-induced killer (CIK) cells, which are active immune cells, with an oncolytic virus. According to the press release, these have both been used as stand-agents. However, this is the first time they will be used in conjunction. Investigators anticipate the CIK cells will protect the oncolytic virus and deliver it to the cancer cells in the body to attack primary tumors and metastatic disease. Preclinical studies have found that the combination may trigger a long-lasting immune response and protect against disease recurrence.1
The first-in-human study aims to enroll 24 participants aged 18 years or older at the time of consent. The enrolled subjects will undergo leukapheresis to enable the ex vivo generation of CIK cells. To be eligible, patients must have histologically confirmed diagnosis of either, triple negative adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer, or gastric cancer. Additionally, subjects must have relapsed disease or be refractory or intolerant to standard care, iRECIST evaluable disease, an ECOG performance status of 0 to 2, and adequate hematologic and organ function.2
Patients with new or progressive brain metastasis, have a history of autoimmune disease, human immunodeficiency virus, or have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medication are not eligible to participate. Additionally, pregnant women or those nursing an infant are also not eligible.2
The study has a primary outcome of adverse events (AEs) and dose-limiting toxicities (DLTs), which will be measured based on the frequency of treatment-emergent AEs and DLTs within 28 days of a single dose. Secondary outcomes include biodistribution of CRX100, immune response to the drug, and early antitumor activity.2
"With the first patient now dosed in our Phase 1 trial, we have crossed an important milestone in furthering the clinical development of CRX100, which we believe has enormous potential as a single therapeutic designed to launch a multi-mechanistic attack against multiple cancer types," said Pamela Contag, PhD, president and chief executive officer, BioEclipse, in a press release. "The need for more effective treatment options, especially for patients with cancers refractory to standard therapies is both urgent and unmet. With enrollment now underway at three clinical trial sites, we look forward to reporting top line data later this year."1