ImmunityBio, a developer of immunotherapy treatments, has begun dosing patients in a Phase 1 clinical trial evaluating the effectiveness of its CAR-NK (CD19 t-haNK) cell therapy candidate for the treatment of relapsed non-Hodgkin’s lymphoma (NHL).
In the trial, dubbed QUILT 106, CD19-targeted high-affinity natural killer cells (t-haNK) will be tested first as a standalone treatment. After assessing safety, the therapy is combined with rituximab, a standard NHL treatment, for participants with selected CD19+ and CD20+ relapsed/refractory B-cell NHL.
This open-label clinical study, taking place in South Africa, aims to enrol up to 10 participants. Full enrolment is expected by Q1 2025, with initial data anticipated in H2 2025.
QUILT 106 aims to collect critical data on NHL, which has a significant incidence in the region but limited treatment options.
This trial in South Africa aligns with ImmunityBio’s US-based QUILT 3.092 study, also a Phase 1 open-label trial evaluating CD19 t-haNK as a standalone treatment and in combination with the company’s IL-15 superagonist Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) and rituximab for relapsed or refractory NHL.
CD19 t-haNK is derived from the parental activated NK (aNK) cell line, NK-92. The therapy combines chimeric antigen receptor (CAR) targeting with antibody-dependent cellular cytotoxicity (ADCC) through a modified aNK cell line expressing both a CD19-targeted CAR and a high-affinity variant of CD16, aiming to produce targeted antitumor effects.
The primary endpoint of the QUILT 106 trial is to assess the safety and preliminary effectiveness of CD19 t-haNK alone and with rituximab in participants with relapsed/refractory B-cell NHL.
Initially, participants will be administered a three-week cycle of CD19 t-haNK as a single-agent treatment. After a one-week safety pause, they receive another three-week cycle with CD19 t-haNK and rituximab.
Multiple assessments will be conducted to evaluate safety and efficacy in participants with active disease following at least two lines of chemotherapy.
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.”
In April 2024, ImmunityBio received approval from the US Food and Drug Administration (FDA) for Anktiva in combination with Bacillus Calmette-Guérin (BCG). This treatment is intended for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) that includes carcinoma in situ (CIS), with or without papillary tumours.
