On January 16, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported updated efficacy and safety results from the ongoing QUILT-106 clinical study (NCT06334991) evaluating an off-the-shelf allogeneic CD19 chimeric antigen receptor natural killer cell therapy (CAR-NK). This CD19 t-haNK (CAR-NK) is a targeted high-affinity natural killer (NK) cell therapy engineered to express a CD19-specifc chimeric antigen receptor (CAR) used in combination with rituximab (anti-CD20) for patients with Waldenström Non-Hodgkins lymphoma, a rare B-cell malignancy.

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Updated follow-up demonstrates sustained complete responses with durations now extending to 15 months and ongoing, with 100% disease control observed to date. Patients who failed standards of care received a total of eight doses of cell therapy in the outpatient setting without lymphodepletion which requires chemotherapy. The tumors were targeted with both CD19 and CD20 immunotherapies by infusing CD19 CAR NK cells with rituximab, two doses per cycle every 21 days for a total of four cycles (eight doses of NK-CAR and six doses of rituximab) and no further therapy thereafter. Response to therapy was evaluated after two cycles.

To date four patients with Waldenstrom Non-Hodgkin Lymphoma have been enrolled and all remain in clinical disease control. Two patients are evaluable for long-term follow-up and continue to demonstrate durable complete remission at 7 and 15 months and ongoing, respectively, despite receiving no additional treatment after the initial eight doses of immunotherapy.

Both the rapid onset of complete remission (after only two cycles) and the durability of complete response following treatment cessation underscores the potential for long-term immune-mediated disease control without continuous therapy.

"This updated follow-up reinforces the central thesis that restoring and activating the immune system can deliver durable control of disease without chemotherapy or lymphodepletion," said Patrick Soon‑Shiong, MD, Founder, Executive Chairman, and Global Chief Medical and Scientific Officer of ImmunityBio. "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."

In two patients evaluable for long-term follow up who presented with extensive disease at baseline, one with multiple lymphomatous bone lesions and one with approximately 95% bone marrow infiltration by tumor cells, complete responses were observed after only four doses of CAR-NK + rituximab.

The patient with significant bone marrow involvement had complete bone morphological remission. In this patient in which 95% of the bone marrow was overtaken and replaced by tumor cells, the CR after four doses has been maintained now for 15 months and is ongoing as of this date with no further treatment after a total of eight doses.

These findings represent 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, administered entirely in the outpatient setting. This approach eliminates the need for cytotoxic conditioning for lymphodepletion or inpatient hospitalization, addressing key limitations associated with conventional CAR-T therapies.

"These data highlight a favorable safety and efficacy profile that is particularly important for patients with indolent yet incurable lymphomas," said Lennie Sender, M.D., Chief Medical Officer, Liquid Tumors and Cell Therapy at ImmunityBio. "To date, all patients have been treated as outpatients with no serious adverse events, demonstrating the feasibility of delivering potent cellular immunotherapy without the morbidity traditionally associated with cell-based treatments."

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. The updated results from QUILT-106 support off-the-shelf CD19 CAR-NK as a next-generation cell therapy for liquid tumors, combining durable efficacy with an outpatient-based treatment.

Enrollment and follow-up in QUILT-106 are ongoing, and additional clinical updates will be provided as more patients become evaluable and response durability continues to mature.

QUILT-106 was designed to examine CD19 CAR NK as a single experiential therapy combined with rituximab. A followup study is being designed to test the further combination of the NK-CAR with ANKTIVA (nogapendekin alfa inbakicept; N-803), a superagonist IL-15, and rituximab to build on the success of the QUILT-106 in indolent lymphoma including Waldenström’s Macroglobulinemia.

ImmunityBio’s CD19 CAR-NK Therapy

CD19 CAR-NK is a targeted high-affinity natural killer cell therapy – an off-the-shelf, allogeneic NK cell line engineered to express a CD19-specific chimeric antigen receptor (CAR) and a high-affinity CD16 (FcγRIIIa 158V) receptor. This design enables dual anti-tumor mechanisms: direct CAR-mediated cytotoxicity and augmented antibody-dependent cellular cytotoxicity when paired with anti-CD20 monoclonal antibody rituximab. Combining CD19 CAR-NK cells with rituximab could thereby target CD19⁺/CD20⁺ lymphoma cells to enhance tumor cell killing.

About ANKTIVA (nogapendekin alfa inbakicept)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

(Press release, ImmunityBio, JAN 16, 2026, View Source [SID1234662070])