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

Conditions

• Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab — BIOLOGICAL
  Intravenous infusion 375 mg/m\^2.
• N-803 — BIOLOGICAL
  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.

Study Details

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.

Key Dates

Start date

Apr 17, 2015

Status verified

Jul 2024

Primary completion

Dec 13, 2020

Completion

Dec 13, 2020

Study Design

Enrollment

43 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1 Cohort 1: N-803 - IV 1 ug/kg
• Experimental: Phase 1 Cohort 2: N-803 - IV 3 ug/kg
• Experimental: Phase 1 Cohort 3: N-803 - IV 6 ug/kg
• Experimental: Phase 1 Cohort 4: N-803 - SQ 6 ug/kg
• Experimental: Phase 1 Cohort 5: N-803 - SQ 10 ug/kg
• Experimental: Phase 1 Cohort 6: N-803 - SQ 15 ug/kg
• Experimental: Phase 1 Cohort 7: N-803 - SQ 20 ug/kg
• Experimental: Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg
• Experimental: Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg

Primary Outcome Measure

MTD or MED of N-803: IV 1, 3, 6 μg/kg, SQ 6, 10, 15, 20 μg/kg [ Time Frame: 9 months ]

Locations (4)

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