ImmunityBio has announced the commencement of a Phase I clinical trial evaluating its CD19 targeted high-affinity natural killer (t-haNK) cell therapy for the treatment of non-Hodgkin’s lymphoma (NHL), with the dosing of the first patients.
The CD19-t-haNK cell therapy uses a stable clonal NK cell line derived from the parental-activated NK (aNK) cell line (NK-92).
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ImmunityBio executive chairman, founder and global chief scientific and medical officer Patrick Soon-Shiong said: “This trial is important for ImmunityBio as our first clinical study of our CAR-NK, CD19 t-haNK cell line, as well as one of our first studies in liquid tumours.
“We have chosen to undertake this trial because Sub-Saharan African and, in particular, South African populations are often overlooked when it comes to advanced clinical research, despite the need for innovative immunotherapies in the region.”
The QUILT 106 trial is a Phase I, first-in-human (FIH), open-label study. It will initially test CD19 t-haNK cells as a single agent and, upon establishing safety, will combine them with the standard NHL treatment rituximab.
The primary endpoint is to evaluate the preliminary efficacy and safety of the CAR-NK therapy.
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By GlobalDataThis trial plans to enrol up to ten participants across Pretoria, Johannesburg and Bloemfontein.
It 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.
Full enrolment for this Phase I study is anticipated by the first quarter of 2025, with expectations to release topline data in the latter half of the same year.
This South African study mirrors ImmunityBio’s US-based QUILT 3.092 trial, which also investigates CD19 t-haNK in combination with ANKTIVA and rituximab for relapsed or refractory NHL.
In August 2024, the company announced the launch of Phase I/II QUILT 502 clinical trial of ANKTIVA plus the investigational AdHER2DC vaccine, for treating patients with HER2-expressing endometrial cancer.
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