QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors
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Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
50estimated
Sites
2
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-06-21 | actual | When the study began enrolling |
| Primary completion | 2026-05-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-05-31 | estimated | The whole study's end, after follow-up |
| First posted | 2021-05-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Metastatic Solid Tumor
Interventions
- Biological: M-CENK, Suspension for Infusion, Cryopreserved (M-CENK) (Cohort 2 part B)
- Biological: N-803 (Cohort 2 part B)
- Other: Apheresis collection of MNCs (part A)
Primary outcomes
what the primary-completion date above is the date OFPrimary Objective (cohort 1 and cohort 2, part A subjects): Determine the safety of mononuclear cell (MNC) apheresis collection by the number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) related to apheresis.
measured Study Day 1, assessed for up to 1 week
Primary Objective (cohort 1 and cohort 2, part A subjects): Determine the safety of mononuclear cell (MNC) apheresis collection by the number of participants with clinically significant laboratory tests.
measured From Baseline/Screening through Study Day 1, assessed for up to 1 day
Primary Objective (cohort 1 and cohort 2, part A subjects): Determine the safety of mononuclear cell (MNC) apheresis collection by number of participants with abnormal vital signs.
measured From Baseline/Screening through Study Day 1, assessed for up to 28 days
Primary Objective (cohort 2, part B subjects): Evaluate the overall safety profile of M-CENK and N-803 for SC administration by the number of TEAEs and SAEs after the first dose of M-CENK and the first dose of N-803 (M-CENK Dose Number 1)
measured From M-CENK Dose Number 1 up to 30 days, assessed for up to 30 days
Primary Objective (cohort 2, part B subjects): Evaluate the overall safety profile of M-CENK and N-803 for SC administration by the number of participants with clinically significant laboratory tests
measured From M-CENK Dose Number 1, assessed for up to 1 day
Primary Objective (cohort 2, part B subjects): Evaluate the overall safety profile of M-CENK and N-803 for SC administration by the number of participants with abnormal vital signs
measured From M-CENK Dose Number 1, assessed for up to 1 day
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