QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 21, 2021

Primary Completion Date

May 31, 2025

Study Completion Date

May 31, 2025

Conditions
Metastatic Solid Tumor
Interventions
BIOLOGICAL

M-CENK, Suspension for Infusion, Cryopreserved (M-CENK) (Cohort 2 part B)

M-CENK will be administered up to 10 times weekly via intravenous (IV) infusion starting on study day 1 with a minimum of 7 days between each M-CENK dose. The dose of MCENK will be 0.25 - 0.75 × 10e9 cells per infusion.

BIOLOGICAL

N-803 (Cohort 2 part B)

N-803 15 μg/kg will be administered subcutaneously prior to every other dose of M-CENK for up to 5 doses of N-803.

OTHER

Apheresis collection of MNCs (part A)

Subjects in cohort 1A will participate in apheresis collection of lymphocytes (part A) and will not receive any investigational therapy in this study.

Trial Locations (2)

90245

Chan Soon-Shiong Institute for Medicine, El Segundo

92663

Hoag Memorial Hospital Presbyterian, Newport Beach

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ImmunityBio, Inc.

INDUSTRY