First Patients Dosed in Phase 1 Clinical Study of ImmunityBio’s CAR-NK Cell Therapy for the Treatment of Relapsed B-Cell Non-Hodgkin Lymphoma
ImmunityBio (NASDAQ: IBRX) has initiated dosing in its Phase 1 clinical trial of CAR-NK cell therapy for treating relapsed B-cell Non-Hodgkin Lymphoma. The QUILT 106 trial, testing CD19-targeted high-affinity natural killer cells, represents the first NK cell-based therapy study in Africa. The trial will enroll up to 10 participants across three South African cities. Initially testing the therapy as a single agent, the study will later combine it with rituximab after safety confirmation. Full enrollment is expected in Q1 2025, with topline data anticipated in H2 2025. This trial mirrors the company's U.S.-based QUILT 3.092 study.
ImmunityBio (NASDAQ: IBRX) ha avviato la somministrazione nella sua fase 1 dello studio clinico sulla terapia con cellule CAR-NK per il trattamento del linfoma non-Hodgkin a cellule B recidivante. Il trial QUILT 106, che testa cellule natural killer ad alta affinità mirate a CD19, rappresenta il primo studio di terapia basata su cellule NK in Africa. Il trial recluterà fino a 10 partecipanti in tre città sudafricane. Inizialmente sarà testata la terapia come agente singolo, mentre successivamente la si combinerà con il rituximab dopo la conferma di sicurezza. Il reclutamento completo è previsto per il primo trimestre del 2025, con i dati preliminari attesi nel secondo semestre del 2025. Questo trial riflette lo studio QUILT 3.092 basato negli Stati Uniti dell'azienda.
ImmunityBio (NASDAQ: IBRX) ha iniciado la administración en su ensayo clínico de fase 1 sobre la terapia con células CAR-NK para tratar el linfoma no Hodgkin de células B en recaída. El ensayo QUILT 106, que evalúa células asesinas naturales de alta afinidad dirigidas a CD19, representa el primer estudio de terapia basada en células NK en África. El ensayo inscribirá hasta 10 participantes en tres ciudades sudafricanas. Inicialmente se probará la terapia como un agente único y, más adelante, se combinará con rituximab tras la confirmación de seguridad. Se espera que la inscripción completa se complete en el primer trimestre de 2025, con datos preliminares anticipados para el segundo semestre de 2025. Este ensayo refleja el estudio QUILT 3.092 de la compañía con sede en EE.UU.
ImmunityBio (NASDAQ: IBRX)는 B세포 비호지킨 림프종 재발 치료를 위한 CAR-NK 세포 치료의 1상 임상 시험에서 투약을 시작했습니다. CD19을 타겟으로 하는 고친화성 자연살해세포를 테스트하는 QUILT 106 시험은 아프리카에서 처음으로 NK 세포 기반 치료 연구를 대표합니다. 이 시험은 세 개의 남아프리카 도시에서 최대 10명의 참가자를 모집할 예정입니다. 처음에는 단일 제제로 치료를 테스트하고, 나중에 안전성 확인 후 리툭시맙과 혼합하여 진행합니다. 전체 모집은 2025년 1분기에 완료될 것으로 예상됩니다, 상반기 동안 주요 데이터가 기대됩니다. 이 시험은 미국에 본사를 두고 있는 회사의 QUILT 3.092 연구와 유사합니다.
ImmunityBio (NASDAQ: IBRX) a commencé à administrer des doses dans son essai clinique de phase 1 sur la thérapie par cellules CAR-NK pour le traitement du lymphome non hodgkinien à cellules B en rechute. L'essai QUILT 106, testant des cellules tueuses naturelles à haute affinité ciblant CD19, représente la première étude de thérapie basée sur des cellules NK en Afrique. L'essai recrutera jusqu'à 10 participants dans trois villes sud-africaines. Au départ, la thérapie sera testée comme agent unique, puis sera combinée avec le rituximab après confirmation de la sécurité. Le recrutement complet est prévu pour le premier trimestre 2025, avec des données préliminaires attendues au second semestre 2025. Cet essai reflète l'étude QUILT 3.092 basée aux États-Unis de l'entreprise.
ImmunityBio (NASDAQ: IBRX) hat die Dosisvergabe in seiner Phase-1-Studie zur CAR-NK-Zelltherapie zur Behandlung von rezidivierendem B-Zell-Nicht-Hodgkin-Lymphom eingeleitet. Die QUILT 106 Studie, die hochaffine natürliche Killerzellen, die auf CD19 gerichtet sind, testet, stellt die erste NK-Zell-basierte Therapie-Studie in Afrika dar. Die Studie wird bis zu 10 Teilnehmer in drei Städten Südafrikas einschreiben. Zunächst wird die Therapie als Einzelmittel getestet, später wird sie nach Bestätigung der Sicherheit mit Rituximab kombiniert. Die vollständige Einschreibung wird im ersten Quartal 2025 erwartet, mit den wichtigsten Daten, die im zweiten Halbjahr 2025 erwartet werden. Diese Studie spiegelt die US-amerikanische QUILT 3.092 Studie des Unternehmens wider.
- First clinical trial of company's CAR-NK cell therapy in liquid tumors
- Geographic expansion into African market with first NK cell-based therapy study in the continent
- Addressing significant medical need in South Africa, where NHL is among top 5 diagnosed cancers
- Small trial size of only 10 participants
- Extended timeline with enrollment completion not expected until Q1 2025
- Results won't be available until H2 2025
Insights
The initiation of a Phase 1 trial for ImmunityBio's CAR-NK cell therapy represents a significant milestone in the company's oncology pipeline. This novel approach combines the natural killing ability of NK cells with CAR technology targeting CD19, a well-validated target in B-cell lymphomas. The dual-pronged strategy of testing it as both monotherapy and in combination with rituximab could potentially enhance treatment outcomes.
The trial's 10-patient enrollment target and expected completion in Q1 2025 provides a clear timeline for initial safety and efficacy data. The parallel U.S. trial (QUILT 3.092) testing the therapy with IL-15 superagonist adds another valuable data stream. While the geographical focus on South Africa is strategic for market access, investors should note that this early-phase trial primarily aims to establish safety rather than efficacy.
- Company’s first clinical trial studying CAR-NK (CD19 t-haNK) cellular therapy in liquid tumors
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First natural killer cell-based cellular therapy study conducted in the continent of
Africa - Complete enrollment currently expected in Q1 2025
This is the first cellular-targeted natural killer (NK) cell therapy study ever to be conducted in
“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 tumors,” said Patrick Soon-Shiong, M.D., Executive Chairman, Founder and Global Chief Scientific and Medical Officer at ImmunityBio. “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.”
Full patient enrollment in this Phase 1 study of CD19 t-haNK is currently expected in the first quarter of calendar year 2025 with topline data readout expected in the second half of the calendar year 2025.
This study, being conducted in
About the QUILT 106 Study
The Phase 1, first-in-human (FIH), open-label study is designed to enroll up to 10 participants at sites in
About CAR-NK, CD19 t-haNK
CD19 t-haNK is a human, allogeneic, stable clonal NK cell line generated from the parental activated NK (aNK) cell line (NK-92). Based on the demonstrated therapeutic efficacy of chimeric antigen receptor (CAR) targeting and on the important role of FcγR-mediated antibody-dependent cellular cytotoxicity (ADCC) in the effectiveness of therapeutic IgG1 monoclonal antibodies, it was hypothesized that modification of the parental aNK cell line to stably express both a CD19-targeted CAR and the high-affinity variant of CD16 would result in potent and selective antitumor activity. Therefore, the novel CD19 t-haNK cells have been genetically engineered to stably express 3 main proteins: (1) a human CD19-targeted CAR; (2) the high-affinity variant of the human Fcγ receptor (FcγRIIIa/CD16a 158V) for enhanced ADCC; and (3) endoplasmic reticulum-retained version of human interleukin-2 (ERIL-2) for independent growth.
Non-Hodgkin Lymphoma
Non-Hodgkin lymphoma (NHL) is a heterogeneous disease that most commonly originates in B lymphocytes. In 2020, 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. According to Global Cancer Observatory (Sung 2021), the incidence of NHL is
About ImmunityBio
ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit www.immunitybio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding clinical trial plans and timing, patient enrollment and treatment, timing of data read outs, market and prevalence data, the regulatory review process and timing thereof, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA and use in cancer vaccines and across multiple tumor types, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others. Statements in this presentation that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “is,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding clinical trial patient enrollment and timing and potential results, including with respect to the trial described herein, (ii) risks and uncertainties related to the regulatory submission and review process, (iii) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (iv) whether clinical trials will result in registrational pathways and the risks and uncertainties regarding the regulatory submission, review and approval process, (v) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (vi) potential delays in product availability and regulatory approvals, (vii) ImmunityBio’s ability to retain and hire key personnel, (viii) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (ix) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (x) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xi) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xii) ImmunityBio’s ability to obtain, maintain, protect and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the
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Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media
Sarah Singleton
ImmunityBio
+1 415-290-8045
Sarah.Singleton@ImmunityBio.com
Source: ImmunityBio, Inc.
FAQ
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