NCT06334991

Study for Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma

Open-Label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With Rituximab in Subjects With Selected CD19+ and CD20+ Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Open Label, Phase 1 study of CD19 t-haNK as a single agent and combination with rituximab in subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin Lymphoma( NHL).

Detailed description

This is a phase 1, first-in-human (FIH), open-label study to evaluate the safety of CD19 t-haNK as a single agent and the safety and preliminary efficacy of CD19 t haNK in combination with rituximab in subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin lymphoma (NHL). Up to 10 subjects will receive at least 1 dose of study drug. The initial 3 subjects will receive study drug in a staggered fashion, with a 7 day interval between each subject to evaluate any toxicities. Subjects will initially receive a single 3 week cycle of the CD19 t haNK as a single-agent regimen. Following a 1-week safety pause, subjects will then receive a 3 week cycle of CD19 t-haNK in combination with rituximab. Subjects will then undergo the first tumor assessment. Subjects with no evidence of progressive disease (PD) will be eligible to receive up to 2 additional 3 week cycles of CD19 t haNK in combination with rituximab.

Conditions

• Non-Hodgkin Lymphoma Refractory/ Relapsed

Interventions

Type	Name	Description
BIOLOGICAL	CD19 t-haNK	CD19t-haNK erived from the parental NK-92 (aNK) cell line, CD19 t-haNK is a human, allogeneic, NK cell line that has been engineered to express a CAR targeting CD19. Similar to the haNK cell line, CD19 t haNK has also been engineered to produce endoplasmic reticulum-retained IL 2 and the high-affinity (158V) variant of the Fcγ receptor (FcγRIIIa/CD16a), and thereby has enhanced CD16-targeted ADCC capabilities. CD19 t-haNK is similar to PD L1 t-haNK, differing only in the CAR that is expressed (CD19 vs PD-L1). 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.

Timeline

• Start date: 2024-08-23
• Primary completion: 2026-03-30
• Completion: 2027-03-30
• First posted: 2024-03-28
• Last updated: 2026-04-01

Locations

3 sites across 1 country: South Africa

Regulatory

• FDA-regulated drug study