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New drug PIT565 takes on tough blood cancers in early trial

NCT ID NCT05397496

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

61 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male or female patients ≥18 years of age at the date of signing the informed consent form * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 NHL patient population * Refractory or relapsed B-NHL * Must have relapsed after or failed to respond to at least two prior treatment therapies including an αCD20 monoclonal antibody containing chemotherapy combination regimen * Must have at least one bi-dimensionally measurable nodal lesion or one bi-dimensionally measurable extranodal lesion, as measured on positron emission tomography-computed tomography (PET/CT) scan ALL patient population * Refractory or relapsed CD19-positive B-ALL * Morphologic disease in the bone marrow (≥ 5% blasts) Exclusion Criteria: * History of severe hypersensitivity to any ingredient of the study treatment or its excipients * Contraindication to tocilizumab * History of ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection * Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type * Active central nervous system (CNS) involvement by malignancy or presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within the 2 weeks prior to the start of study treatment * Active, known or suspected autoimmune disease other than patients with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur * Patients receiving systemic treatment with any immunosuppressive medication Other protocol-defined inclusion/exclusion criteria may apply.

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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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