QUILT-3.002: N-803 in Patients With Relapse/Refractory iNHL in Conjunction With Rituximab
- Conditions
- Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphoma
- Interventions
- Biological: RituximabBiological: N-803
- Registration Number
- NCT02384954
- Lead Sponsor
- Altor BioScience
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phase 1 Cohort 7: N-803 - SQ 20 ug/kg N-803 - Phase 1 Cohort 1: N-803 - IV 1 ug/kg N-803 - Phase 1 Cohort 6: N-803 - SQ 15 ug/kg Rituximab - Phase 1 Cohort 6: N-803 - SQ 15 ug/kg N-803 - Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg N-803 - Phase 1 Cohort 1: N-803 - IV 1 ug/kg Rituximab - Phase 1 Cohort 5: N-803 - SQ 10 ug/kg Rituximab - Phase 1 Cohort 5: N-803 - SQ 10 ug/kg N-803 - Phase 1 Cohort 4: N-803 - SQ 6 ug/kg N-803 - Phase 1 Cohort 7: N-803 - SQ 20 ug/kg Rituximab - Phase 1 Cohort 2: N-803 - IV 3 ug/kg Rituximab - Phase 1 Cohort 2: N-803 - IV 3 ug/kg N-803 - Phase 1 Cohort 3: N-803 - IV 6 ug/kg Rituximab - Phase 1 Cohort 3: N-803 - IV 6 ug/kg N-803 - Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg Rituximab - Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg N-803 - Phase 1 Cohort 4: N-803 - SQ 6 ug/kg Rituximab - Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg Rituximab -
- Primary Outcome Measures
Name Time Method Overall Response Rate 60 months 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.
MTD or MED of N-803: IV 1, 3, 6 μg/kg, SQ 6, 10, 15, 20 μg/kg 9 months 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.
Number of Participants With Treatment Emergent Adverse Events 30 days after last dose, up to 40 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Washington University School of Medicine Oncology
🇺🇸Saint Louis, Missouri, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States