Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies (NCT05397496)
A Phase I, Open-label, Multi-center Study of PIT565 in Patients With Relapsed and/or Refractory B-cell Malignancies
🩺 Plain-English Summary (8th-Grade Level)
This is an open-label, multicenter, phase I study, which primary objective is to characterize the safety and tolerability of PIT565 and to identify maximal tolerated doses (MTDs) and/or recommended doses (RDs), schedule and route of administration in relapsed and/or refractory B-cell Non-Hodgkin lymphoma (R/R B-NHL) and relapsed and/or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).
Who can join: Review the eligibility criteria below.
Location: University Of Miami — Miami, Florida
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- University Of Miami — Miami, Florida
- University of Chicago Medical Center — Chicago, Illinois
- The University of Kansas Clinical Research Ctr — Fairway, Kansas
- Memorial Sloan Kettering Cancer Ctr — New York, New York
- Oregon Health Sciences University — Portland, Oregon
- Novartis Investigative Site — Ghent,
- Novartis Investigative Site — Beijing,
- Novartis Investigative Site — Shanghai,
- Novartis Investigative Site — Tianjin,
- Novartis Investigative Site — Créteil,
- Novartis Investigative Site — Marseille,
- Novartis Investigative Site — Tel Aviv,
- Novartis Investigative Site — Reggio Emilia, RE
- Novartis Investigative Site — Kashiwa, Chiba
- Novartis Investigative Site — Singapore,
- Novartis Investigative Site — Singapore,
- Novartis Investigative Site — Barcelona,
- Novartis Investigative Site — Barcelona,
💰 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 § 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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💡 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.