QUILT-3.052: NANT Non-Hodgkin Lymphoma (NHL) Vaccine: Combination Immunotherapy in Subjects With Relapsed CD20-positive NHL

Summary

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with with CD20-positive NHL who have progressed on or after rituximab therapy.

Conditions

• Non Hodgkin Lymphoma

Interventions

BIOLOGICAL

avelumab

Fully human anti-PD-L1 IgG1 lambda monoclonal antibody

BIOLOGICAL

bevacizumab

Recombinant human anti-VEGF IgG1 monoclonal antibody

DRUG

capecitabine

5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine

DRUG

cyclophosphamide

2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

DRUG

5-Fluorouracil (5-FU)

5-fluoro-2,4 (1H,3H)-pyrimidinedione

DRUG

leucovorin

Calcium N-\[p-\[\[\[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl\]methyl\]amino\]benzoyl\]-L-glutamate (1:1)

DRUG

nab-paclitaxel

5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine

DRUG

Lovaza

Omega-3-acid ethyl esters

DRUG

Oxaliplatin

cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum

DRUG

rituximab

Chimeric murine/human anti-CD20 monoclonal IgG1 kappa antibody

RADIATION

Stereotactic Body Radiation Therapy

(SBRT)

BIOLOGICAL

ALT-803

recombinant human super agonist interleukin-15 (IL-15) complex

BIOLOGICAL

ETBX-061

Ad5 \[E1-, E2b-\]-mucin 1\[MUC1\]

BIOLOGICAL

haNK

NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous \[IV\] Infusion

Sponsors & Collaborators

• ImmunityBio, Inc.

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-31

Primary Completion

2019-01-31

Completion

2021-12-23

FDA Drug

Yes