RecruitingPhase 1NCT05618925

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 an IL-15 Superagonist (N-803) and Rituximab in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma.

Sponsor

ImmunityBio, Inc.

Enrollment

20 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

Non Hodgkin's Lymphoma Refractory/Relapsed

Summary

Open-label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With an IL-15 Superagonist (N-803) and Rituximab in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma. Up to 20 subjects will be enrolled and randomized 1:1 to 1 of 2 cohorts, as outlined below. The initial 3 subjects will be sequentially enrolled in a staggered fashion, with a 7 day interval between each subject to enable the capture and monitoring of any acute and subacute toxicities.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination of two antibody-based drugs in people with non-Hodgkin lymphoma (a type of blood cancer affecting B-cells) that has come back or is no longer responding to prior treatments. **You may be eligible if...** - You are 18 or older with B-cell non-Hodgkin lymphoma that expresses both CD19 and CD20 proteins on the cancer cells - Your cancer has progressed after at least two rounds of prior treatment, including a prior anti-CD20 drug like rituximab - You have measurable disease on imaging - You have either had a stem cell transplant already or are not eligible for one - Your general health score is 0 or 1 and your expected survival is more than 12 weeks - No cancer has been found in the brain or spinal fluid **You may NOT be eligible if...** - Your cancer does not express CD19 or CD20 on the most recent biopsy - You have active cancer in the brain - You have not had at least two prior lines of treatment - Your organ function is insufficient for the treatment 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.

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Interventions

DRUGN803

nogapendekin alfa inbakicept (also known as ALT-803; recombinant human superagonist interleukin-15 (IL-15) complex \[also known as IL 15N72D:IL-15RαSu/IgG1 Fc complex\])

BIOLOGICALCD19t-haNK suspension

Derived 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).

DRUGCyclophosphamide

Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate and has the molecular formula C7H15Cl2N2O2P•H2O and a molecular weight of 279.1.

DRUGFludarabine

Fludarabine phosphate is a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-β-D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. The chemical name for fludarabine phosphate is 9H-Purin-6-amine, 2-fluoro-9-(5-0-phosphono β-D-arabino-furanosyl) (2-fluoro-ara-AMP). The molecular formula of fludarabine phosphate is C10H13FN5O7P and it has a molecular weight of 365.2.

DRUGRituximab

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.

Locations(2)

Hoag Memorial Hospital

Newport Beach, California, United States

Texas Oncology

Tyler, Texas, United States

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NCT05618925