Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 22, 2025

Primary Completion Date

March 15, 2026

Study Completion Date

March 15, 2027

Conditions
Non Hodgkin's Lymphoma Refractory/Relapsed
Interventions
DRUG

N803

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

BIOLOGICAL

CD19t-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).

DRUG

Cyclophosphamide

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.

DRUG

Fludarabine

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.

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.

Trial Locations (2)

75702

RECRUITING

Texas Oncology, Tyler

92663

RECRUITING

Hoag Memorial Hospital, Newport Beach

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ImmunityBio, Inc.

INDUSTRY

NCT05618925 - Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma | Biotech Hunter | Biotech Hunter