New drug PIT565 takes on tough blood cancers in early trial

NCT ID NCT05397496

Ongoing Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This early-phase study tests a new biologic drug called PIT565 in 61 adults with B-cell non-Hodgkin lymphoma or B-cell acute lymphoblastic leukemia that has come back or stopped responding to treatment. The main goals are to check the drug's safety, find the best dose, and see how well it is tolerated. It is an open-label study, meaning everyone knows they are getting the experimental drug.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: PIT565 (a biologic drug given by IV or injection)
What this could lead to: If it works, this could point toward a new treatment option for people with hard-to-treat B-cell blood cancers.
What could go wrong: This is a very early Phase 1 trial with only 61 people, focused on safety and dosing. It may not show strong anti-cancer effects, and side effects could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia B-cell neoplasm B-cell non-Hodgkin lymphoma Burkitt lymphoma non-Hodgkin lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) B-CELL NON-HODGKIN LYMPHOMA (B-NHL)

Contacts and locations

Locations

Memorial Sloan Kettering Cancer Ctr

New York, New York, 10065, United States
Novartis Investigative Site

Ghent, 9000, Belgium
Novartis Investigative Site

Beijing, 100730, China
Novartis Investigative Site

Shanghai, 200032, China
Novartis Investigative Site

Tianjin, 300020, China
Novartis Investigative Site

Créteil, 94010, France
Novartis Investigative Site

Marseille, 13273, France
Novartis Investigative Site

Tel Aviv, 6423906, Israel
Novartis Investigative Site

Reggio Emilia, RE, 42123, Italy
Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan
Novartis Investigative Site

Singapore, 119074, Singapore
Novartis Investigative Site

Singapore, 169608, Singapore
Novartis Investigative Site

Barcelona, 08035, Spain
Novartis Investigative Site

Barcelona, 08036, Spain
Oregon Health Sciences University

Portland, Oregon, 97239, United States
The University of Kansas Clinical Research Ctr

Fairway, Kansas, 66205, United States
University Of Miami

Miami, Florida, 33136, United States
University of Chicago Medical Center

Chicago, Illinois, 60637, United States

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