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

NCT05397496 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2026-05-15

No results posted yet for this study

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).

Conditions

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

Interventions

BIOLOGICAL

PIT565

Intravenous (i.v.) infusion or Subcutaneous (s.c.) injection

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2026-08-20
Completion
2026-08-20
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • China
  • France
  • Israel
  • Italy
  • Japan
  • Singapore
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05397496 on ClinicalTrials.gov