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ImmunityBio Announces Early QUILT-106 Phase I Data Showing Complete Responses In Waldenstrom Macroglobulinemia Patients Treated With CD19 CAR-NK Therapy

Author: Benzinga Newsdesk | August 13, 2025 07:36am
  • Single-agent CD19 CAR-NK cell therapy achieved a complete response in third-line Waldenstrom macroglobulinemia (WM), a type of non-Hodgkin lymphoma
  • Second patient maintains an ongoing complete response at six months with CD19 CAR-NK in combination with rituximab and a third WM patient has been enrolled in the study
  • First study to demonstrate the potential for complete responses with a chemotherapy-free immunotherapy in late-stage WM patients validating the power of NK cells

ImmunityBio ((IBRX), a leading immunotherapy company, announced today early findings from its QUILT-106 Phase I trial, showing highly promising complete responses in the first two patients treated to date with late-stage Waldenstrom macroglobulinemia (WM)—a type of non-Hodgkins lymphoma (NHL)—using its CD19 CAR-NK (CD19 t-haNK) natural killer cell therapy.

QUILT-106 (NCT06334991) is a first-in-human trial evaluating the safety and preliminary efficacy of CD19 CAR-NK cell therapy alone and in combination with rituximab in patients with relapsed or refractory (R/R) CD19⁺CD20⁺ B-cell NHL. The disease remains challenging to treat, and WM is considered incurable with existing treatment options, making novel immunotherapies an important avenue of exploration for potential effective treatments.

In the first two evaluable patients with WM who were heavily pretreated, an entirely chemotherapy-free, immunotherapy regimen induced encouraging responses. Both patients tolerated the regimen with no significant toxicities. Notably, all infusions (including CAR-NK cells and cytokines) were administered in an outpatient setting. One patient achieved a complete response (CR) with CD19 CAR NK monotherapy, while the second patient achieved CR with CD19 CAR-NK in combination with rituximab. Remission was maintained and is ongoing for six months to date.

Posted In: IBRX

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