OncRef

Clinical Trial: NCT05397496

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Novartis Pharmaceuticals
Information Provided By:Novartis
Last Update Posted:2026-07-28

Study Overview

Brief 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

Conditions

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

Intervention / Treatment

  • Biological: PIT565

Other Study ID Numbers

  • CPIT565A12101
  • 2022-000367-45

Start Date (Actual)

2022-10-03

Primary Completion Date (Estimated)

2027-01-04

Study Completion Date (Estimated)

2027-01-04

Enrollment (Actual)

61

Study Type

Interventional

Phase

Phase 1