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ACTIVE NOT RECRUITING
NCT05397496
PHASE1

Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

BIOLOGICAL

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