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NCT05397496 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL), sponsored by Novartis Pharmaceuticals.

Active
Registry status
Phase 1
Development phase
61
Enrollment target
18
Study locations

NCT05397496 is a Phase 1 study of B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL) that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 61 participants, below the 123-participant average among 6 other B-cell Acute Lymphoblastic Leukemia (B-ALL) trials with a reported enrollment target (50% lower). The trial reports 18 study locations across 8 states.

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The verdict

NCT05397496, a Phase 1 study of B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL), is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
61 participants
Enrollment target
18
Study locations

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 Studied

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

Interventions

  • BIOLOGICAL PIT565

Study Locations (18)

Other

  • Novartis Investigative Site - Ghent
  • Novartis Investigative Site - Beijing
  • Novartis Investigative Site - Shanghai
  • Novartis Investigative Site - Tianjin
  • Novartis Investigative Site - Créteil
  • Novartis Investigative Site - Marseille
  • Novartis Investigative Site - Tel Aviv
  • Novartis Investigative Site - Singapore
  • Novartis Investigative Site - Singapore
  • Novartis Investigative Site - Barcelona
  • Novartis Investigative Site - Barcelona

Florida

  • University Of Miami - Miami

Illinois

  • University of Chicago Medical Center - Chicago

Kansas

  • The University of Kansas Clinical Research Ctr - Fairway

New York

  • Memorial Sloan Kettering Cancer Ctr - New York

Oregon

  • Oregon Health Sciences University - Portland

RE

  • Novartis Investigative Site - Reggio Emilia

Chiba

  • Novartis Investigative Site - Kashiwa

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2022-10-03
Est. Completion 2026-05-14
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT05397496

The ClinicalTrials.gov registry entry for NCT05397496 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 123-participant average among 6 other B-cell Acute Lymphoblastic Leukemia (B-ALL) trials with a reported enrollment target (50% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with B-cell Acute Lymphoblastic Leukemia (B-ALL) appearing as the primary indexed condition, and to 1 intervention - of which PIT565 is the first listed.

NCT05397496 reports 18 study locations spanning 8 distinct geographic areas - top geographies include Other, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT05397496 about?

NCT05397496 is a clinical study titled "Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies". 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 lym...

What is the current status of trial NCT05397496?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2022-10-03. Estimated completion is 2026-05-14.

What conditions does trial NCT05397496 study?

This clinical trial studies the following conditions: B-cell Acute Lymphoblastic Leukemia (B-ALL), B-cell Non-Hodgkin Lymphoma (B-NHL).

What interventions are being tested in trial NCT05397496?

The interventions under investigation include: PIT565 (BIOLOGICAL).

Who is sponsoring clinical trial NCT05397496?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05397496 being conducted?

This trial has 18 study locations across Florida, Illinois, Kansas, New York, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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