Open-Label, Phase 2 Chemotherapy-Free Study ofCD19 t-haNK and NAI in Combination With Rituximab in Participants With Relapsed/Refractory B-Cell Indolent Non-Hodgkin Lymphoma. 40 Participant will be screened for 20 subjects enrollment.
Age ≥ 18 to ≤ 75 years old.
Able to understand and provide a signed informed consent that fulfils the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
Have completed ≥ 2 lines of cytotoxic chemotherapy.
Have received rituximab or another anti-CD20 antibody.
Histologically documented large B-cell lymphomas (eg, diffuse large B-cell lymphoma [DLBCL], anaplastic large cell lymphoma [ALCL], follicular large cell lymphoma, mantle cell lymphoma), primary central nervous system (CNS) lymphoma, chronic lymphocytic leukemia (CLL), Burkitt and Burkitt-like lymphoma.
Known hypersensitivity or allergy to any component of the study medications, including sulfa containing study medication(s) (eg, albumin [human], dimethyl sulfoxide [DMSO]).
ANC < 1000 cells/mm3.
Platelet count < 100,000 cells/mm3.
Single group
CD19 t-haNK- IV Administration
Biological/VaccineCD19-Directed Therapies: CD19-targeted therapies, are biologic agents specifically designed to recognize and eliminate CD19-expressing B-cell malignancies. These therapies differ from traditional chemotherapy or small molecule inhibitors by leveraging the patient's immune system to achieve targeted cytotoxicity. Their mechanism of action involves direct binding to the CD19 antigen on malignant B cells, leading to immune-mediated cell death.
N-803
DrugN-803 Subcutaneous (SQ): N-803 is a novel IL-15 superagonist immunotherapy administered subcutaneously. It is designed to enhance the proliferation and activation of natural killer (NK) cells and CD8+ T cells without stimulating regulatory T cells. N-803 SQ differs from other cytokine therapies due to its improved pharmacokinetic profile, enhanced in vivo activity, and reduced toxicity.
rituximab
DrugRituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD and has a binding affinity for the CD20 antigen of approximately 8.0 nM.
ORR in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)
OS (time from study treatment initiation to death)
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded using the National Cancer Institute (NCI) CTCAE Version 6.0
Clinically important changes in laboratory tests - Hematology
Laboratory tests include hematology and will be assessed/measured per the site-specific normal lab ranges
Clinically important changes in laboratory tests - Chemistry
Laboratory tests include chemistry and will be assessed/measured per the site-specific normal lab ranges
Clinically important changes in laboratory tests - Urinalysis
Laboratory tests include urinalysis and will be assessed/measured per the site-specific normal lab ranges
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