๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-09

QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors (NCT04898543)

Phase 1 Open-Label Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: ImmunityBio, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This is a two-part, open-label phase 1 study to evaluate safety and preliminary efficacy of M-CENK Suspension for Infusion, Cryopreserved, and N-803 for subcutaneous administration in subjects with locally advanced or metastatic solid tumors. The study consists of two cohorts: cohort 1 includes subjects with either newly diagnosed solid tumors who have not received prior therapy or subjects who have received prior first line treatment; and cohort 2 that includes subjects with relapsed/refractory (r/r) solid tumors who have progressive disease after receiving โ‰ฅ 2 prior therapies. The two cohorts will be conducted simultaneously.

Who can join: Review the eligibility criteria below.

Location: Chan Soon-Shiong Institute for Medicine โ€” El Segundo, California

Age range: 18 Years to 100 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (2 Sites)

  • Chan Soon-Shiong Institute for Medicine โ€” El Segundo, California
  • Hoag Memorial Hospital Presbyterian โ€” Newport Beach, California

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—