RecruitingPhase 1NCT06334991

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

Sponsor

ImmunityBio, Inc.

Enrollment

10 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

Non-Hodgkin Lymphoma Refractory/ Relapsed

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).

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new immunotherapy drug combination in people with certain types of B-cell lymphoma (a blood cancer) that has come back or stopped responding to previous treatments. The treatment targets proteins on the surface of cancer cells called CD19 and CD20. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a CD19- and CD20-positive B-cell non-Hodgkin lymphoma (NHL) - You have received at least 2 prior chemotherapy regimens including rituximab or a similar drug - You have measurable disease on imaging - Your cancer has relapsed or is no longer responding to prior treatment **You may NOT be eligible if...** - Your lymphoma is primary CNS lymphoma, Burkitt lymphoma, or CLL - You have serious active infections or uncontrolled health conditions - You have had certain high-intensity prior treatments (e.g., CAR-T therapy) without adequate recovery time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALCD19 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.