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
๐ฉบ 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 โฅ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- Chan Soon-Shiong Institute for Medicine โ El Segundo, California
- Hoag Memorial Hospital Presbyterian โ Newport Beach, California
๐ฐ 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.
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- Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM) โ Baltimore, Maryland
- TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3) โ Los Angeles, California
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.