What's Happening?
ImmunityBio, Inc. has announced the launch of a Phase 2 clinical trial, ResQ215B, to evaluate a novel chemotherapy-free and lymphodepletion-free combination immunotherapy for patients with indolent B-cell
non-Hodgkin lymphoma (iNHL), including Waldenström’s Macroglobulinemia. This trial will assess the efficacy of ImmunityBio’s off-the-shelf CD19-targeted high-affinity natural killer (NK) cell therapy (CD19 t-haNK) in combination with nogapendekin-alfa inbakicept (ANKTIVA®), an IL-15 superagonist, and the anti-CD20 monoclonal antibody rituximab. The regimen is designed to enhance NK and T-cell activity, potentially overcoming tumor resistance to rituximab and improving response durability. The study builds on promising results from a Phase 1 study where durable complete responses were observed in heavily pretreated patients with iNHL.
Why It's Important?
This development is significant as it represents a potential shift in the treatment paradigm for indolent lymphomas, which are typically considered incurable with current therapies. The chemotherapy-free approach could offer a less toxic alternative to traditional treatments, reducing the need for hospitalization and improving patient quality of life. The trial's success could pave the way for more accessible and patient-friendly cancer treatments, addressing a high unmet medical need in oncology. If successful, this therapy could significantly impact the treatment landscape for indolent B-cell malignancies, offering hope for improved outcomes in a patient population with limited options.
What's Next?
The ResQ215B study will enroll adults with CD19+/CD20+ indolent NHL who have relapsed or are refractory after at least two prior lines of therapy. Treatment will be administered in 21-day outpatient cycles without preconditioning chemotherapy. The trial aims to determine whether the addition of ANKTIVA can enhance immune-mediated tumor control. The results of this study could influence future clinical development plans and regulatory interactions, potentially leading to new treatment options for patients with indolent lymphomas.
