ImmunityBio’s stock is up after its off-the-shelf allogeneic CD19 chimeric antigen receptor natural killer cell therapy (CAR-NK) showed over 15 months of complete response in patients with Waldenström Non-Hodgkins lymphoma, a rare B-cell malignancy.
In the ongoing Phase I QUILT-106 study (NCT06334991), CAR-NK, in combination with rituximab, led to sustained complete responses with durations extending over 15 months, with 100% disease control observed to date.
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The trial enrolled patients who failed to respond to standard of care (SoC). Patients received eight doses of cell therapy in the outpatient setting without lymphodepletion, which requires chemotherapy. Patients received a total of eight doses of CAR-NK and six doses of rituximab.
Four patients with Waldenström Non-Hodgkin lymphoma were enrolled in the study, and all remain in clinical disease control. Two of these patients are continuing to demonstrate durable complete remission at seven and 15 months, respectively. Both responses are ongoing, despite the patients receiving no additional treatment.
The patient with 15-month complete remission presented with approximately 95% bone marrow infiltration by tumour cells, and had complete bone morphological remission after four doses, which has been maintained.
Dr Patrick Soon‑Shiong, founder and executive chairman of ImmunityBio, said: “Seeing complete responses persist beyond a year after treatment has stopped, in patients who had exhausted available options, represents a meaningful advance for patients with this rare disease of Waldenström lymphoma and validates CAR-NK as a potential next-generation immunotherapy platform.”
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By GlobalDataAfter the data was released, ImmunityBio’s stock rose by 39.74%, from a $3.95 close on 15 January to a $5.52 close on 16 January. The stock jump was likely compounded by the company also announcing that Anktiva (nogapendekin alfa inbakicept) sales rose 700% year-on-year, reaching $113m in 2025.
ImmunityBio says that CAR-NK’s data is the first chemotherapy-free and lymphodepletion-free immunotherapy regimen combining off-the-shelf allogeneic CD19 CAR-NK cells with rituximab to demonstrate 100% disease control in Waldenström Non-Hodgkins lymphoma, with it also having been administered entirely in the outpatient setting.
Waldenström Non-Hodgkins lymphoma remains an area of significant unmet medical need, particularly for patients who relapse or become refractory to available targeted and antibody-based therapies. It is a rare form of B-cell lymphoma that causes white blood cells to produce excessive Immunoglobulin M (IgM) proteins, which leads to blood thickening and abnormal cell buildup in the bone marrow, lymph nodes, and spleen.
Enrolment and follow-up in QUILT-106 is ongoing and ImmunityBio is also planning a follow-up study to evaluate CAR-NK in combination with Anktiva and rituximab in patients with indolent lymphoma, including Waldenström’s Non-Hodgkins lymphoma.
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