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TerminatedNCT02384954Updated Jul 3, 2024Results posted

QUILT-3.002: N-803 in Patients With Relapse/Refractory iNHL in Conjunction With Rituximab

A Phase 1/2 interventional study of Rituximab and N-803 in Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphoma, sponsored by Altor BioScience. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Altor BioScience (part of ImmunityBio, Inc.) · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Change in drug product development strategy.
Phase
Phase 1/2
Study type
Interventional
Enrollment
43
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation study of N-803 in patients with relapse/refractory indolent B cell non-Hodgkin lymphoma in conjunction with rituximab.

Read the detailed description

The purpose of this study is to evaluate the safety and tolerability, identify the Maximum Tolerated Dose (MTD) or the Minimum Efficacious Dose (MED) and designate a dose level for Phase 2. Also characterize the immunogenicity, pharmacokinetic profile, and biomarker serum levels of N-803 in treated patients.

The effect of N-803 on the peripheral absolute lymphocyte counts and white blood cell counts, the number, phenotype and repertoire of peripheral blood T (total and subsets) and NK cells will be evaluated. In addition, a subset of patients will be evaluated for changes in lymph node immune composition. Anti-tumor responses and survival data will also be collected in this trial.

02

Conditions studied

  • Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphoma

Keywords

  • Lymphoma
  • indolent B Cell
  • non-Hodgkin Lymphoma
  • Cancer
  • Immunotherapy
  • Relapsed
  • Refractory
  • Rituximab
  • Interleukin-15
  • Absolute Lymphocyte Count
  • White Blood Cell
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Small Lymphocytic Lymphoma
  • Lymphoplasmacytic Lymphoma
  • anti-CD20
03

In context

Recurrence

4,347 studies on the registry are indexed under Recurrence; 1,004 are open to participants now.

This study's enrollment of 43 is below the median of 50 across 3,429 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

Altor BioScience is the lead sponsor of 15 studies on the registry; none are open to participants now.

First submitted before Altor BioScience became part of ImmunityBio, Inc..

Browse Altor BioScience studies →All ImmunityBio, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of iNHL (Follicular lymphoma grade 1, 2, 3a; marginal zone lymphoma; small lymphocytic lymphoma or lymphoplasmacytic lymphoma) after treatment with at least 1 or more prior rituximab-containing regimens.

    • Anti-CD20 mAb-refractory disease is defined as progressive disease while on rituximab (or another treatment of an anti-CD20 monoclonal antibody) or progression within 6 months of rituximab-containing (or another treatment of an anti-CD20 antibody-containing) therapy.
    • Anti-CD20 mAb-sensitive disease is defined by a response to a prior rituximab-containing (or another treatment of an anti-CD20 monoclonal antibody) regimen, and relapse more than 6 months from the last administration of rituximab-containing (or another treatment of an anti-CD20 antibody-containing) therapy.

  • Measurable disease:

    • At least one lymph node group ≥ 1.5 cm in longest transverse dimension. Patients with cutaneous only disease may be enrolled if they have a clearly measurable skin lesion.
    • Relapsed or Refractory iNHL that has progressed during or following 1 or more prior systemic rituximab-containing (or another treatment of an anti-CD20 antibody-containing) regimens for lymphoma

PRIOR/CONCURRENT THERAPY:

  • No anti-lymphoma treatments within 28 days before the start of study treatment.
  • Must have recovered from side effects of prior treatments.

PATIENT CHARACTERISTICS:

Performance Status

  • ECOG 0, 1, or 2

Renal Function • Glomerular Filtration Rate (GFR) > 40mL/min or Serum creatinine ≤ 1.5 X ULN

Bone Marrow Reserve

  • Platelets ≥30,000/uL
  • Hemoglobin ≥ 8g/dL
  • Absolute Lymphocytes ≥800/uL
  • ANC/AGC ≥750/uL

Hepatic Function

  • Total bilirubin ≤ 2.0 X ULN (unless Gilbert's Syndrome or disease infiltration of liver is present)
  • AST, ALT ≤ 3.0 X ULN, or ≤ 5.0 X ULN (if liver lymphoma is present)
  • No positive Hep C serology or active Hep B infection

Cardiovascular

  • No congestive heart failure \< 6 months
  • No unstable angina pectoris \< 6 months
  • No myocardial infarction \< 6 months
  • No history of ventricular arrhythmias or severe cardiac dysfunction
  • No history of uncontrollable supraventricular arrhythmias
  • No NYHA Class > II CHF
  • No marked baseline prolongation of QT/QTc interval

Pulmonary

  • Normal clinical assessment of pulmonary function

Other

  • Negative serum pregnancy test if female and of childbearing potential
  • Women who are not pregnant or nursing
  • Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
  • No known autoimmune disease other than corrected hypothyroidism
  • No known prior organ allograft or allogeneic transplantation
  • Not HIV positive
  • No active CNS involvement with lymphoma
  • No psychiatric illness/social situation that would limit compliance
  • No other illness that in the opinion of the investigator would exclude the subject from participating in the study
  • Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
  • No active systemic infection requiring parenteral antibiotic therapy
  • No disease requiring systemic immunosuppressive therapy (inhaled or topical steroids are allowed). Adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
  • No known histologic transformation from iNHL to DLBCL
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Phase 1 Cohort 1: N-803 - IV 1 ug/kg

    Biological: Rituximab · Biological: N-803

  • Experimental
    Phase 1 Cohort 2: N-803 - IV 3 ug/kg

    Biological: Rituximab · Biological: N-803

  • Experimental
    Phase 1 Cohort 3: N-803 - IV 6 ug/kg

    Biological: Rituximab · Biological: N-803

  • Experimental
    Phase 1 Cohort 4: N-803 - SQ 6 ug/kg

    Biological: Rituximab · Biological: N-803

  • Experimental
    Phase 1 Cohort 5: N-803 - SQ 10 ug/kg

    Biological: Rituximab · Biological: N-803

  • Experimental
    Phase 1 Cohort 6: N-803 - SQ 15 ug/kg

    Biological: Rituximab · Biological: N-803

  • Experimental
    Phase 1 Cohort 7: N-803 - SQ 20 ug/kg

    Biological: Rituximab · Biological: N-803

  • Experimental
    Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg

    Biological: Rituximab · Biological: N-803

  • Experimental
    Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg

    Biological: Rituximab · Biological: N-803

Interventions

  • BiologicalRituximab

    Intravenous infusion 375 mg/m\^2.

    Also known as: Rituxin

  • BiologicalN-803

    Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.

06

What researchers measure

Primary outcomes

  1. MTD or MED of N-803: IV 1, 3, 6 μg/kg, SQ 6, 10, 15, 20 μg/kg

    Maximum Tolerated Dose level (MTD) is defined as a dose level at which \<2 out of 6 patients experienced Dose Limiting Toxicity (DLT) and that is one level below a dose that was not tolerated. Minimal Efficacious Dose (MED) is defined as a dose level which produces an Absolute Lymphocyte Count (ALC) ≥25,000/μL sustained for 14 days or a total WBC ≥35,000/μL sustained for 14 days among 2/3 or 4/6 of patients. The elevated ALC cannot be attributed to circulating lymphoma cells. Dose levels for N-803 1, 3, 6 μg/kg IV, and 6, 10, 15, 20 μg/kg subcutaneous (SQ) were used to determine the MTD or MED.

    Time frame: 9 months

  2. Number of Participants With Treatment Emergent Adverse Events

    Treatment Emergent Adverse Event is defined as any AE that begins or worsens in grade after the start of study treatment until 30 days after the last dose of study treatment or end of study period, whichever is later.

    Time frame: 30 days after last dose, up to 40 weeks

  3. Overall Response Rate

    For Phase 1 and 2, overall response rate (ORR) will be calculated as the ratio of the number of patients who demonstrated response (CR+PR) divided by the number of patients in the Evaluable population. Response and disease progression criteria were defined by the 2007 IHP response assessments for malignant lymphoma.

    Time frame: 60 months

07

Results

Posted Jul 3, 2024

Participant flow

Phase 1
Participant flow — Phase 1
MilestonePhase 1 Cohort 1: N-803 - IV 1 ug/kgPhase 1 Cohort 2: N-803 - IV 3 ug/kgPhase 1 Cohort 3: N-803 - IV 6 ug/kgPhase 1 Cohort 4: N-803 - SQ 6 ug/kgPhase 1 Cohort 5: N-803 - SQ 10 ug/kgPhase 1 Cohort 6: N-803 - SQ 15 ug/kgPhase 1 Cohort 7: N-803 - SQ 20 ug/kgPhase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kgPhase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
Started333333300
Completed131233300
Not completed202100000
Withdrew: Progressive disease201100000
Withdrew: Adverse event001000000
Phase 2
Participant flow — Phase 2
MilestonePhase 1 Cohort 1: N-803 - IV 1 ug/kgPhase 1 Cohort 2: N-803 - IV 3 ug/kgPhase 1 Cohort 3: N-803 - IV 6 ug/kgPhase 1 Cohort 4: N-803 - SQ 6 ug/kgPhase 1 Cohort 5: N-803 - SQ 10 ug/kgPhase 1 Cohort 6: N-803 - SQ 15 ug/kgPhase 1 Cohort 7: N-803 - SQ 20 ug/kgPhase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kgPhase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
Started0000000169
Completed0000000136
Not completed000000033
Withdrew: Progressive disease000000012
Withdrew: Adverse event000000011
Withdrew: Failure to meet continuation criteria000000010

Outcome measures

PrimaryMTD or MED of N-803: IV 1, 3, 6 μg/kg, SQ 6, 10, 15, 20 μg/kg

Maximum Tolerated Dose level (MTD) is defined as a dose level at which \<2 out of 6 patients experienced Dose Limiting Toxicity (DLT) and that is one level below a dose that was not tolerated. Minimal Efficacious Dose (MED) is defined as a dose level which produces an Absolute Lymphocyte Count (ALC) ≥25,000/μL sustained for 14 days or a total WBC ≥35,000/μL sustained for 14 days among 2/3 or 4/6 of patients. The elevated ALC cannot be attributed to circulating lymphoma cells. Dose levels for N-803 1, 3, 6 μg/kg IV, and 6, 10, 15, 20 μg/kg subcutaneous (SQ) were used to determine the MTD or MED.

Time frame:
9 months
Reported as:
Number · SQ μg/kg
MTD or MED of N-803: IV 1, 3, 6 μg/kg, SQ 6, 10, 15, 20 μg/kg
SQ μg/kgPhase 1 Cohort 7: N-803 - SQ 20 μg/kg
MTD or MED of N-803: IV 1, 3, 6 μg/kg, SQ 6, 10, 15, 20 μg/kg20
PrimaryNumber of Participants With Treatment Emergent Adverse Events

Treatment Emergent Adverse Event is defined as any AE that begins or worsens in grade after the start of study treatment until 30 days after the last dose of study treatment or end of study period, whichever is later.

Time frame:
30 days after last dose, up to 40 weeks
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events
ParticipantsPhase 1 Cohort 1: N-803 - IV 1 ug/kgPhase 1 Cohort 2: N-803 - IV 3 ug/kgPhase 1 Cohort 3: N-803 - IV 6 ug/kgPhase 1 Cohort 4: N-803 - SQ 6 ug/kgPhase 1 Cohort 5: N-803 - SQ 10 ug/kgPhase 1 Cohort 6: N-803 - SQ 15 ug/kgPhase 1 Cohort 7: N-803 - SQ 20 ug/kgPhase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kgPhase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
Phase 13333333——
Phase 2———————169
PrimaryOverall Response Rate

For Phase 1 and 2, overall response rate (ORR) will be calculated as the ratio of the number of patients who demonstrated response (CR+PR) divided by the number of patients in the Evaluable population. Response and disease progression criteria were defined by the 2007 IHP response assessments for malignant lymphoma.

Time frame:
60 months
Reported as:
Number · percentage of subjects
Overall Response Rate
percentage of subjectsPhase 1 Cohort 1: N-803 - IV 1 ug/kgPhase 1 Cohort 2: N-803 - IV 3 ug/kgPhase 1 Cohort 3: N-803 - IV 6 ug/kgPhase 1 Cohort 4: N-803 - SQ 6 ug/kgPhase 1 Cohort 5: N-803 - SQ 10 ug/kgPhase 1 Cohort 6: N-803 - SQ 15 ug/kgPhase 1 Cohort 7: N-803 - SQ 20 ug/kgPhase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kgPhase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
Phase 133 (0.8 to 90.6)33 (0.8 to 90.6)67 (9.4 to 99.2)33 (0.8 to 90.6)67 (9.4 to 99.2)67 (9.4 to 99.2)100 (29.2 to 100)——
Phase 2———————80 (51.9 to 95.7)33 (7.5 to 70.1)

Adverse events

Collected over All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase 1 Cohort 1: N-803 - IV 1 ug/kg0/3 (0%)0/3 (0%)3/3 (100%)
Phase 1 Cohort 2: N-803 - IV 3 ug/kg0/3 (0%)0/3 (0%)3/3 (100%)
Phase 1 Cohort 3: N-803 - IV 6 ug/kg0/3 (0%)1/3 (33.3%)3/3 (100%)
Phase 1 Cohort 4: N-803 - SQ 6 ug/kg0/3 (0%)1/3 (33.3%)3/3 (100%)
Phase 1 Cohort 5: N-803 - SQ 10 ug/kg0/3 (0%)0/3 (0%)3/3 (100%)
Phase 1 Cohort 6: N-803 - SQ 15 ug/kg0/3 (0%)0/3 (0%)3/3 (100%)
Phase 1 Cohort 7: N-803 - SQ 20 ug/kg0/3 (0%)1/3 (33.3%)3/3 (100%)
Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg0/16 (0%)3/16 (18.8%)16/16 (100%)
Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg0/9 (0%)2/9 (22.2%)9/9 (100%)
Most frequent serious events
Most frequent serious events
EventPhase 1 Cohort 1: N-803 - IV 1 ug/kgPhase 1 Cohort 2: N-803 - IV 3 ug/kgPhase 1 Cohort 3: N-803 - IV 6 ug/kgPhase 1 Cohort 4: N-803 - SQ 6 ug/kgPhase 1 Cohort 5: N-803 - SQ 10 ug/kgPhase 1 Cohort 6: N-803 - SQ 15 ug/kgPhase 1 Cohort 7: N-803 - SQ 20 ug/kgPhase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kgPhase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
Small intestinal obstructionGastrointestinal disorders0/30/31/30/30/30/30/30/160/9
Cerebrovascular accidentNervous system disorders0/30/30/31/30/30/30/30/160/9
Urinary tract infectionInfections and infestations0/30/30/30/30/30/31/31/160/9
Pleural effusionRespiratory, thoracic and mediastinal disorders0/30/30/30/30/30/30/30/161/9
NeutropeniaBlood and lymphatic system disorders0/30/30/30/30/30/30/30/161/9
PyrexiaGeneral disorders0/30/30/30/30/30/30/30/161/9
Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders0/30/30/30/30/30/30/31/160/9
Sinus node dysfunctionCardiac disorders0/30/30/30/30/30/30/31/160/9
AscitesGastrointestinal disorders0/30/30/30/30/30/30/31/160/9
Most frequent other events
Showing 10 of 150
Most frequent other events
EventPhase 1 Cohort 1: N-803 - IV 1 ug/kgPhase 1 Cohort 2: N-803 - IV 3 ug/kgPhase 1 Cohort 3: N-803 - IV 6 ug/kgPhase 1 Cohort 4: N-803 - SQ 6 ug/kgPhase 1 Cohort 5: N-803 - SQ 10 ug/kgPhase 1 Cohort 6: N-803 - SQ 15 ug/kgPhase 1 Cohort 7: N-803 - SQ 20 ug/kgPhase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kgPhase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
NauseaGastrointestinal disorders2/32/33/32/30/31/31/34/160/9
VomitingGastrointestinal disorders1/32/33/31/30/31/30/30/160/9
ChillsGeneral disorders2/33/32/33/33/33/33/312/166/9
FatigueGeneral disorders1/32/33/31/31/33/33/37/166/9
Injection site reactionGeneral disorders0/30/30/33/33/33/33/313/168/9
PyrexiaGeneral disorders2/32/32/31/32/33/33/313/169/9
Abdominal painGastrointestinal disorders1/31/32/30/30/30/30/30/160/9
ConstipationGastrointestinal disorders0/31/31/31/31/32/31/32/162/9
DiarrhoeaGastrointestinal disorders0/30/31/31/31/31/32/33/161/9
Localised oedemaGeneral disorders0/30/30/30/30/32/31/31/160/9

Baseline characteristics

Age, Continuous
Age, Continuous(years)Phase 1 Cohort 1: N-803 - IV 1 ug/kgPhase 1 Cohort 2: N-803 - IV 3 ug/kgPhase 1 Cohort 3: N-803 - IV 6 ug/kgPhase 1 Cohort 4: N-803 - SQ 6 ug/kgPhase 1 Cohort 5: N-803 - SQ 10 ug/kgPhase 1 Cohort 6: N-803 - SQ 15 ug/kgPhase 1 Cohort 7: N-803 - SQ 20 ug/kgPhase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kgPhase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kgTotal
Phase 158.0 ± 1.0064.7 ± 7.3769.3 ± 8.3960.0 ± 4.5865.0 ± 10.4468.3 ± 10.2162.0 ± 3.61——63.9 ± 7.28
Phase 2———————59.5 ± 11.3969.1 ± 12.5463.0 ± 12.48
Sex: Female, Male
Sex: Female, Male(Participants)Phase 1 Cohort 1: N-803 - IV 1 ug/kgPhase 1 Cohort 2: N-803 - IV 3 ug/kgPhase 1 Cohort 3: N-803 - IV 6 ug/kgPhase 1 Cohort 4: N-803 - SQ 6 ug/kgPhase 1 Cohort 5: N-803 - SQ 10 ug/kgPhase 1 Cohort 6: N-803 - SQ 15 ug/kgPhase 1 Cohort 7: N-803 - SQ 20 ug/kgPhase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kgPhase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kgTotal
Phase 1 — Female2200223——11
Phase 1 — Male1133110——10
Phase 2 — Female———————10212
Phase 2 — Male———————6713
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase 1 Cohort 1: N-803 - IV 1 ug/kgPhase 1 Cohort 2: N-803 - IV 3 ug/kgPhase 1 Cohort 3: N-803 - IV 6 ug/kgPhase 1 Cohort 4: N-803 - SQ 6 ug/kgPhase 1 Cohort 5: N-803 - SQ 10 ug/kgPhase 1 Cohort 6: N-803 - SQ 15 ug/kgPhase 1 Cohort 7: N-803 - SQ 20 ug/kgPhase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kgPhase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kgTotal
Phase 1 — American Indian or Alaska Native0000000000
Phase 1 — Asian0000000000
Phase 1 — Native Hawaiian or Other Pacific Islander0000000000
Phase 1 — Black or African American0010000001
Phase 1 — White33233330020
Phase 1 — More than one race0000000000
Phase 1 — Unknown or Not Reported0000000000
Phase 2 — American Indian or Alaska Native———————000
Phase 2 — Asian———————022
Phase 2 — Native Hawaiian or Other Pacific Islander———————000
Phase 2 — Black or African American———————011
Phase 2 — White———————14620
Phase 2 — More than one race———————101
Phase 2 — Unknown or Not Reported———————101
Patients with relapse/refractory indolent B cell non-Hodgkin lymphoma
Patients with relapse/refractory indolent B cell non-Hodgkin lymphoma(Participants)Phase 1 Cohort 1: N-803 - IV 1 ug/kgPhase 1 Cohort 2: N-803 - IV 3 ug/kgPhase 1 Cohort 3: N-803 - IV 6 ug/kgPhase 1 Cohort 4: N-803 - SQ 6 ug/kgPhase 1 Cohort 5: N-803 - SQ 10 ug/kgPhase 1 Cohort 6: N-803 - SQ 15 ug/kgPhase 1 Cohort 7: N-803 - SQ 20 ug/kgPhase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kgPhase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kgTotal
Phase 13333333——21
Phase 2———————16925
08

Study locations

4 sites
  • University of Minnesota Cancer Center
    Minneapolis, Minnesota 55455, United States
  • Washington University School of Medicine Oncology
    St Louis, Missouri 63110, United States
  • The Ohio State University
    Columbus, Ohio 43210, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
09

References and documents

Publications

  • Foltz JA, Hess BT, Bachanova V, Bartlett NL, Berrien-Elliott MM, McClain E, Becker-Hapak M, Foster M, Schappe T, Kahl B, Mehta-Shah N, Cashen AF, Marin ND, McDaniels K, Moreno C, Mosior M, Gao F, Griffith OL, Griffith M, Wagner JA, Epperla N, Rock AD, Lee J, Petti AA, Soon-Shiong P, Fehniger TA. Phase I Trial of N-803, an IL15 Receptor Agonist, with Rituximab in Patients with Indolent Non-Hodgkin Lymphoma. Clin Cancer Res. 2021 Jun 15;27(12):3339-3350. doi: 10.1158/1078-0432.CCR-20-4575. Epub 2021 Apr 8. PubMed 33832946 ↗

Related links

Study documents

  • Protocol and statistical analysis plan · Feb 6, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02384954
Lead sponsor
Altor BioScience
Responsible party
Sponsor
First posted
Mar 10, 2015
Start date
Apr 17, 2015
Primary completion
Dec 13, 2020
Completion
Dec 13, 2020
Results posted
Jul 3, 2024
Last update
Jul 3, 2024

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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