A Phase I, Open-label, Multi-center Study of PIT565 in Patients With Relapsed and/or Refractory B-cell Malignancies
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• Signed informed consent must be obtained prior to participation in the study.
• Male or female patients ≥18 years of age at the date of signing the informed consent form
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
⁃ NHL patient population
• Refractory or relapsed B-NHL
• Must have relapsed after or failed to respond to at least two prior treatment therapies including an αCD20 monoclonal antibody containing chemotherapy combination regimen
• Must have at least one bi-dimensionally measurable nodal lesion or one bi-dimensionally measurable extranodal lesion, as measured on positron emission tomography-computed tomography (PET/CT) scan
⁃ ALL patient population
• Refractory or relapsed CD19-positive B-ALL
• Morphologic disease in the bone marrow (≥ 5% blasts)
Locations
United States
Florida
University Of Miami
RECRUITING
Miami
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
New York
Memorial Sloan Kettering Cancer Ctr
RECRUITING
New York
Oregon
Oregon Health Sciences University
RECRUITING
Portland
Other Locations
Belgium
Novartis Investigative Site
RECRUITING
Ghent
China
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Tianjin
France
Novartis Investigative Site
RECRUITING
Créteil
Novartis Investigative Site
RECRUITING
Marseille
Israel
Novartis Investigative Site
RECRUITING
Tel Aviv
Italy
Novartis Investigative Site
WITHDRAWN
Bologna
Novartis Investigative Site
WITHDRAWN
Milan
Novartis Investigative Site
RECRUITING
Reggio Emilia
Novartis Investigative Site
RECRUITING
Rozzano
Japan
Novartis Investigative Site
RECRUITING
Kashiwa
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Barcelona
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Time Frame
Start Date:2022-10-03
Estimated Completion Date:2028-06-05
Participants
Target number of participants:140
Treatments
Experimental: PIT565 Group A (dose escalation part)
PIT565 in adult NHL patients for whom two or more lines of chemotherapy have failed and either having progressed (or relapsed) after autologous hematopoietic stem cell transplantation (HSCT), or being ineligible for or not consenting to the procedure
Experimental: PIT565 Group B (dose escalation part)
PIT565 in adult R/R ALL patients
Experimental: PIT565 Group A1 (dose expansion part)
PIT565 Recommended dose 1 (RD1) in adult R/R large B-cell lymphoma (LBCL) (DLBCL, double/triple hit High-grade B-cell lymphoma (HGBCL), Primary mediastinal large B-cell lymphoma (PMBCL), Follicular lymphoma grade 3B (FL3B)) patients
Experimental: PIT565 Group A2 (dose expansion part)
PIT565 RD2 in adult R/R LBCL (DLBCL, double/triple hit HGBCL, PMBCL, FL3B) patients
Experimental: PIT565 Group B1 (dose expansion part)