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Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies
Sponsor: Novartis Pharmaceuticals
Summary
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).
Official title: A Phase I, Open-label, Multi-center Study of PIT565 in Patients With Relapsed and/or Refractory B-cell Malignancies
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
61
Start Date
2022-10-03
Completion Date
2026-05-14
Last Updated
2026-03-17
Healthy Volunteers
No
Interventions
PIT565
Intravenous (i.v.) infusion or Subcutaneous (s.c.) injection
Locations (18)
University Of Miami
Miami, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
The University of Kansas Clinical Research Ctr
Fairway, Kansas, United States
Memorial Sloan Kettering Cancer Ctr
New York, New York, United States
Oregon Health Sciences University
Portland, Oregon, United States
Novartis Investigative Site
Ghent, Belgium
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Créteil, France
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Tel Aviv, Israel
Novartis Investigative Site
Reggio Emilia, RE, Italy
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Barcelona, Spain