Nikogene is being evaluated for potential use in glioblastoma and malignant solid tumors, subject to protocol-defined inclusion criteria. Target patient populations and lines of therapy are determined by ongoing or planned clinical studies.
• All Patients who meet protocol-defined inclusion criteria
• Confirmed diagnosis aligned with study indication
• Adequate organ function per protocol and investigator assessment
• Ability to provide informed consent
• An off-the-shelf product, providing patients with rapid access to treatment without delay.
• No need to HLA matching, simplifying the treatment process.
• Suitable for allogenic use, broadening its applicability.
• Safe and efficient in treating malignant solid tumors.
• Increases the survival rate of patients.
A positive response to the treatment in 69.5% of patients who received NK cells.
Increasing in the median survival rate to 30 months.
Healthy donors are screened according to protocol and applicable standards. Source cells are collected and processed through controlled steps (isolation, activation/expansion) with in-process controls. Each lot undergoes release testing (identity, purity, viability, potency as available, sterility/bioburden/endotoxin) and is tracked under defined batch records for full traceability. Manufacturing is aligned with Good Manufacturing Practice (GMP) principles, with documentation, change control, and deviation management to support consistent quality.
Administration is performed under the supervision of a qualified healthcare professional according to the study protocol. Common, mild side effects after infusion may include headache, body aches, or low-grade fever, which typically resolve within about 48 hours. Monitoring and supportive care are provided as directed by the investigator. Concomitant medications, dosing, and follow-up schedules are defined by the study protocol.