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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: Active Phase 1 study of B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL), sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Assessment of safety of study drug. A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of CTCAE grade 3 or higher that occurs within the DLT evaluation period (28 days or 35 days depending on the schedule) and that is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications with exceptions provided in the clinical protocol.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2026-05-14 |
| Phase | Phase 1 |
What the registry record for NCT05397496 still lists
NCT05397496 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 123-participant average among 6 other B-cell Acute Lymphoblastic Leukemia (B-ALL) trials with a reported enrollment target (50% lower).
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 lists 18 locations in 8 states (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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