ImmunityBio has announced the start of a Phase I clinical trial of its CD19-targeted high-affinity natural killer (t-haNK) cell therapy for non-Hodgkin’s lymphoma (NHL) in South Africa, with the first patients already dosed. This trial, known as QUILT 106, represents a significant step in exploring innovative immunotherapies in a region often overlooked in advanced clinical research.
The CD19-t-haNK cell therapy utilizes a stable clonal NK cell line derived from the parental-activated NK (aNK) cell line (NK-92). The trial plans to enroll up to ten participants across Pretoria, Johannesburg and Bloemfontein.
Trial Design and Objectives
The QUILT 106 trial is a Phase I, first-in-human, open-label study. Initially, the trial will evaluate CD19 t-haNK cells as a single agent. Upon establishing safety, the study will proceed to combine the cell therapy with rituximab, a standard treatment for NHL. The primary endpoint of the trial is to assess the preliminary efficacy and safety of the CAR-NK therapy.
Patrick Soon-Shiong, ImmunityBio executive chairman, founder, and global chief scientific and medical officer, emphasized the importance of the trial as the company’s first clinical study of its CAR-NK, CD19 t-haNK cell line, and one of their first studies in liquid tumors. He also noted the specific need for innovative immunotherapies in Sub-Saharan African populations, particularly in South Africa.
Strategic Significance and Parallel Studies
This South African study mirrors ImmunityBio’s US-based QUILT 3.092 trial, which is also investigating CD19 t-haNK in combination with ANKTIVA and rituximab for relapsed or refractory NHL. The parallel trials allow for a broader understanding of the therapy's efficacy and safety across different patient populations and treatment settings.
Full enrollment for the Phase I study is anticipated by the first quarter of 2025, with topline data expected to be released in the latter half of the same year. This trial is the first of its kind in South Africa to explore cellular-targeted NK cell therapy, offering critical clinical insights for cancer with limited treatment options in the region.
ImmunityBio's Broader Oncology Pipeline
In August 2024, ImmunityBio also announced the launch of the Phase I/II QUILT 502 clinical trial of ANKTIVA plus the investigational AdHER2DC vaccine for treating patients with HER2-expressing endometrial cancer, highlighting the company's commitment to developing novel immunotherapies across a range of cancer types.
