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NOT YET RECRUITING
NCT07477366
PHASE2

Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma

Sponsor: ImmunityBio, Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: Open-Label, Phase 2 Chemotherapy-Free Study of CD19 t-haNK and NAI in Combination With Rituximab in Participants With Relapsed/Refractory B-Cell Indolent Non-Hodgkin Lymphoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-04

Completion Date

2028-12

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

BIOLOGICAL

CD19 t-haNK- IV Administration

CD19-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.

DRUG

N-803

N-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.

DRUG

rituximab

Rituximab 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.