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

Sponsor
ImmunityBio, Inc.
Study ID
NCT03169790
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • avelumab — BIOLOGICAL
    Fully human anti-PD-L1 IgG1 lambda monoclonal antibody
  • bevacizumab — BIOLOGICAL
    Recombinant human anti-VEGF IgG1 monoclonal antibody
  • capecitabine — DRUG
    5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
  • cyclophosphamide — DRUG
    2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
  • 5-Fluorouracil (5-FU) — DRUG
    5-fluoro-2,4 (1H,3H)-pyrimidinedione
  • leucovorin — DRUG
    Calcium N-\[p-\[\[\[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl\]methyl\]amino\]benzoyl\]-L-glutamate (1:1)
  • nab-paclitaxel — DRUG
    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
  • Lovaza — DRUG
    Omega-3-acid ethyl esters
  • Oxaliplatin — DRUG
    cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
  • rituximab — DRUG
    Chimeric murine/human anti-CD20 monoclonal IgG1 kappa antibody
  • Stereotactic Body Radiation Therapy — RADIATION
    (SBRT)
  • ALT-803 — BIOLOGICAL
    recombinant human super agonist interleukin-15 (IL-15) complex
  • ETBX-061 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-mucin 1\[MUC1\]
  • haNK — BIOLOGICAL
    NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous \[IV\] Infusion

Study Details

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.

Key Dates

Start date
Dec 31, 2017
Status verified
Oct 2017
Primary completion
Jan 31, 2019
Completion
Dec 23, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nant NHL Vaccine
    avelumab, bevacizumab, capecitabine, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, lovaza, oxaliplatin, rituximab, stereotactic body radiation therapy, ALT-803,ETBX-061, and haNK.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 [ Time Frame: 1 year ]

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