NCT05397496

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

A Phase I, Open-label, Multi-center Study of PIT565 in Patients With Relapsed and/or Refractory B-cell Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is an open-label, multicenter, phase I study of PIT565 in patients with R/R B-NHL and R/R B-ALL. The study comprises a dose escalation part of PIT565 in two independent groups (group A: R/R B-NHL and B: R/R B-ALL) and a dose expansion part in three independent groups (R/R large B-cell lymphoma (LBCL) randomized in 1:1 ratio to two RDs (A1 and A2), and R/R B-ALL (B1)). During the dose escalation, the safety (including the dose-dose limiting toxicity (DLT) relationship) and tolerability of PIT565 will be assessed, and schedule(s), route(s) of administration and dose(s) will be identified for use in the expansion part based on the review of these data. The RD will also be guided by the available information on pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity. The dose escalation will be guided by an adaptive Bayesian logistic regression model (BLRM) following the Escalation with Overdose Control (EWOC) principle. Different schedules and routes of administrations will be explored in the dose escalation groups. The dose expansion will further explore the MTD(s) and/or RD(s) and the selected schedule(s) and route of administration(s) in the three patients' groups.

Conditions

• B-cell Non-Hodgkin Lymphoma (B-NHL)
• B-cell Acute Lymphoblastic Leukemia (B-ALL)

Interventions

Type	Name	Description
BIOLOGICAL	PIT565	Intravenous (i.v.) infusion or Subcutaneous (s.c.) injection

Timeline

• Start date: 2022-10-03
• Primary completion: 2026-05-14
• Completion: 2026-05-14
• First posted: 2022-05-31
• Last updated: 2026-03-17

Locations

18 sites across 9 countries: United States, Belgium, China, France, Israel, Italy, Japan, Singapore, Spain

Regulatory

• FDA-regulated drug study