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Active, not recruiting Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT05397496

Public ClinicalTrials.gov record NCT05397496. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 6, 2026, 4:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT05397496
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
61 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 100 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 3, 2022 (Actual)
Primary completion
Jan 4, 2027 (Estimated)
Completion
Jan 4, 2027 (Estimated)
Last update posted
Jul 28, 2026

2022 – 2027

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
University Of Miami Miami Florida 33136 —
University of Chicago Medical Center Chicago Illinois 60637 —
The University of Kansas Clinical Research Ctr Fairway Kansas 66205 —
Memorial Sloan Kettering Cancer Ctr New York New York 10065 —
Oregon Health Sciences University Portland Oregon 97239 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05397496, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 28, 2026 · Synced Oct 6, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05397496 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →