๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-10

Evaluation of NWRD09 for Female Participants With Persistent HPV16 Infection (NCT07536282)

A Phase I/IIa, Randomized, Double Blind, Placebo Controlled, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of NWRD09 Injection in Female Participants With Persistent HPV16 Infection

๐ŸŸก Not Yet Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Newish Biotech (Wuxi) Co., Ltd.

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

This is a two-part, phase I/IIa study, intended to evaluate the safety, tolerability, immunogenicity, and efficacy of NWRD09 in female participants with persistent HPV16 infection, and to determine the MTD, and/or RP2D of NWRD09.

Who can join: Review the eligibility criteria below.

Location: Columbia University Medical Center โ€” New York, New York

Age range: 18 Years to 60 Years

๐Ÿงช Interventions in This Study

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 (1 Sites)

  • Columbia University Medical Center โ€” New York, New York

๐Ÿ“ž Contact the Study Coordinator

Phone: (212) 305-3410

Email: jh3558@cumc.columbia.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

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. Contact the study coordinator using the phone/email above.
  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†—