ImmunityBio, Inc. has announced the dosing of the first patients in its Phase 1 clinical trial, QUILT 106, evaluating a novel CAR-NK cell therapy, CD19 t-haNK, for the treatment of relapsed/refractory B-cell non-Hodgkin's lymphoma (NHL). The study is being conducted in Johannesburg, Pretoria, and Bloemfontein, South Africa.
The QUILT 106 trial (NCT number pending) is an open-label, first-in-human study designed to enroll up to 10 participants with CD19+ and CD20+ relapsed/refractory B-cell NHL who have active disease after completing at least two lines of cytotoxic chemotherapy. The trial will initially assess the safety and preliminary efficacy of CD19 t-haNK as a single agent, followed by a combination regimen with rituximab after a one-week safety pause.
Significance of the Trial
This trial represents ImmunityBio's first clinical study of its CAR-NK, CD19 t-haNK cell line, and one of its first studies in liquid tumors. According to Patrick Soon-Shiong, M.D., Executive Chairman, Founder and Global Chief Scientific and Medical Officer at ImmunityBio, the trial is being conducted in South Africa to address the unmet need for innovative immunotherapies in a region often overlooked in advanced clinical research. NHL is the 6th most common malignancy among people in Sub-Saharan Africa and a significant health concern in South Africa.
CAR-NK Cell Therapy: CD19 t-haNK
CD19 t-haNK is an allogeneic, stable clonal NK cell line derived from the NK-92 cell line. These cells are genetically engineered to express a CD19-targeted CAR, a high-affinity variant of the human Fcγ receptor (FcγRIIIa/CD16a 158V) for enhanced antibody-dependent cellular cytotoxicity (ADCC), and an endoplasmic reticulum-retained version of human interleukin-2 (ERIL-2) for independent growth. This design aims to enhance the cells' ability to target and kill CD19-expressing lymphoma cells.
Trial Design and Endpoints
Participants will receive a single 3-week cycle of CD19 t-haNK as a single agent. Following the safety pause, they will receive a 3-week cycle of CD19 t-haNK in combination with rituximab. The primary endpoint of the trial is to evaluate the safety and preliminary efficacy of the CAR-NK cell therapy. Multiple assessments of safety and efficacy will be conducted throughout the study.
Non-Hodgkin Lymphoma in South Africa
Non-Hodgkin lymphoma (NHL) is a heterogeneous group of malignancies that commonly originate in B lymphocytes. In South Africa, NHL represents a notable proportion of cancer diagnoses. According to the South Africa National Cancer Registry (SANCR 2020), it is estimated that 1 in 174 men and 1 in 288 women will develop NHL. A comparative study indicates that Southern Africa has a higher proportion of high-grade B cell NHL compared to Western Europe and North America.
Anticipated Timeline
Full patient enrollment in the Phase 1 study is expected in the first quarter of 2025, with topline data readout anticipated in the second half of 2025.
