๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-06-30

CSB-321 Ph 1 in Immunotherapy for the Treatment of Cancer (NCT07057349)

Phase 1 Multi-cohort Evaluation of [18F]CSB-321 PET Imaging in Participants Receiving Immunotherapy for the Treatment of Cancer

๐ŸŸก Not Yet Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Cytosite Biopharma Inc.

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

Single-center with the option to expand to multi-center, international, open label, non-randomized, multiple-dose, multi-cohort study, in participants with metastatic or unresectable cancer. Eligible participants will receive an initial injection of \[18F\]CSB-321 followed by PET imaging prior to administration of the I-O therapy and a second and third injection post treatment each with PET imaging. The images will be analyzed for the distribution of radioactivity. Participants will be followed for adverse events up to 3-4 hours post injection. Available clinical, imaging, and histology data will be collected at follow-up to establish the disease progression for evaluation of \[18F\]CSB-321.

Who can join: Review the eligibility criteria below.

Location: Massachusetts General Hospital โ€” Boston, Massachusetts

Age range: 18 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)

  • Massachusetts General Hospital โ€” Boston, Massachusetts

๐Ÿ“ž Contact the Study Coordinator

Phone: (215) 648-1208

Email: kphan@cytositebio.com

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†—