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Phase II Trial Launches of Anktiva in Long COVID Patients
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A new exploratory study will evaluate the safety of Anktiva in patients with long COVID, with secondary and exploratory measures focused on immune cell activity and function.
ImmunityBio has initiated a new Phase II study, COVID-4.019-Long (NCT07123727), to evaluate the safety and effectiveness of Anktiva (nogapendekin alfa inbakicept-pmln) in patients with long COVID.1
Trial objectives and design
The exploratory, single-arm study will look to recruit up to 40 participants who meet the World Health Organization (WHO)’s long COVID criteria. Its main objective is to evaluate the safety of Anktiva administered subcutaneously and has a key secondary measure of assessing the interleukin-15 agonist’s effect on absolute lymphocyte count. Other exploratory objectives include:
- Evaluation of Anktiva’s ability to improve post-COVID natural killer cell and CD8+ T cell counts.
- Assessment of the immunological function of NK cells and CD8+ T cells.
Understanding long COVID
According to the CDC, long COVID is defined as a chronic condition following COVID-19 that is present for three months. It includes a wide range of symptoms which can emerge, persist, resolve, and reemerge over the span of weeks and months.2
In a company statement, Patrick Soon-Shiong, MD, founder, executive chairman and global chief scientific and medical officer of ImmunityBio, said: “We are excited to study Anktiva for the treatment of long COVID, a substantial public health concern. Early in the pandemic, the common assumption was SARS-CoV-2 would prove to be a transient infection, as is the case with coronaviruses in general. But we now know viral nucleic acid and proteins can be in the gut mucosa months after infection. As such, an antiviral strategy looks insufficient to treat or cure long COVID. Based on clinical insights to date, we believe Anktiva may be a new therapeutic option for this chronic and potentially disabling condition by enhancing immune function, facilitating viral clearance, and addressing underlying contributions to long COVID.”
ImmunityBio is also supporting a separate Phase II study of Anktiva for the treatment of long COVID (NCT07108036), which will evaluate safety and tolerability.
Previous approval in bladder cancer
Anktiva is already FDA-approved alongside Bacillus Calmette-Guérin (BCG) as a treatment for patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.3
The approval was based on positive results from the single-arm, multicenter, Phase II/III QUILT-3.032 trial (NCT03022825). Results from a group of 77 patients who received Anktiva with BCG maintenance therapy for up to 37 months showed:
- The complete response rate was 62% (95% CI: 51–73).
- Among responders, 58% maintained a response for at least 12 months and 40% maintained a response for at least 24 months.
- Tumor status was evaluated with cystoscopy and urine cytology and is continuing for up to five years following the beginning of each patient’s participation in the study.
In a company statement from the time of the approval in April 2024, Soon-Shiong said: "Anktiva not only proliferates and activates the patient’s own NK cells and CD8+ killer T cells, but also activates CD4+ T helper cells, thus enhancing the proliferation of memory killer T cells. This novel mechanism of action, which mimics the biology of the dendtritic cell, begins the evolution of immunotherapy beyond T cells alone. The combination of the proliferation of key cancer-killing immune cells, together with the activation of T cells with memory, results in durable complete responses. The ‘triangle offense’ of tumor cell killing by the body’s immune system with long-term memory is the foundation of our efforts to develop a therapeutic cancer vaccine across multiple tumor types, regardless of the site of origin.”
References
1. ImmunityBio Announces Phase 2 Study of ANKTIVA® in Patients with Long COVID. News release. ImmunityBio. August 19, 2025. Accessed August 21, 2025. https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-phase-2-study-anktivar-patients-long-covid?field_nir_news_date_value%5bmin%5d=
2. Long COVID Basics. US Centers for Disease Control and Prevention. July 24, 2025. Accessed August 21, 2025. https://www.cdc.gov/long-covid/about/index.html
3. ImmunityBio Announces FDA Approval of ANKTIVA®, First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer. News release. ImmunityBio. April 22, 2024. Accessed August 21, 2025. https://immunitybio.com/immunitybio-announces-fda-approval-of-anktiva-first-in-class-il-15-receptor-agonist-for-bcg-unresponsive-non-muscle-invasive-bladder-cancer/
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