ImmunityBio's CD19 CAR-NK Therapy Achieves Complete Remission in Relapsed/Refractory Waldenström Macroglobulinemia, Shares Surge 37%

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Recently, ImmunityBio announced itsAllogeneic CD19 CAR-NK Cell TherapyPreliminary results from the QUILT-106 Phase II trial show that all four patients with relapsed/refractory Waldenström macroglobulinemia achieved disease control.Two of the evaluable patients continued to have a complete response at 7 months and 15 months after the end of treatment, respectively.

Affected by this news, the company's stock price rose 37% on the same day. The current market value is $5.44 billion.

ImmunityBio stated,The data from this CAR-NK therapy represents the first immunotherapy regimen combining off-the-shelf allogeneic CD19 CAR-NK cells with rituximab, without the need for chemotherapy or lymphodepletion. It demonstrated a 100% disease control rate in Waldenström's non-Hodgkin lymphoma and was fully administered in an outpatient setting.

The trial enrolled patients who were refractory to standard-of-care therapies. Patients received eight doses of the cell therapy in an outpatient setting,No need for lymphocyte depletion requiring chemotherapyThe patient received a total of eight doses of CAR-NK and six doses of rituximab.

The study enrolled a total of four patients with Waldenström's non-Hodgkin lymphoma, and all patients are currently in a state of clinical disease control. Two of the patients have continued to demonstrate durable complete responses after 7 months and 15 months of treatment, respectively. Despite not receiving any additional treatment, these two cases of remission are still ongoing.

The patient who achieved 15 months of complete remission had a bone marrow infiltration rate of approximately 95% at enrollment. After receiving four doses of therapy, complete bone marrow morphological remission was achieved, and this state was maintained.

At the same time, the company announced the preliminary financial and operational highlights for 2025: full-year net product revenue for 2025 is approximately US$113 million.Year-on-year increase as high as 700%; Revenue in the fourth quarter of 2025 reached $38.3 million, a 20% increase quarter-over-quarter and a 431% increase year-over-year.

Reference: Company official website