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Active, not recruiting Phase 1

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

NCT05397496 · tracked via the Priya Life Science Italy tracker
Phase
Phase 1
Started
2022-10-03
Last updated
2026-07-28

Condition(s) studied

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

Investigational drug(s) / intervention(s)

PIT565 →

PIT565: Intravenous (i.v.) infusion or Subcutaneous (s.c.) injection

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence and severity of Dose Limiting Toxicities (DLTs) — 28 days or 35 days, depending on the dosing schedule
    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.
  • Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) — 21 months
    Assessment of safety of study drug.
  • Frequency of dose interruptions — 21 months
    Assessment of tolerability of study drug
  • Frequency of dose reductions — 21 months
    Assessment of tolerability of study drug
  • Dose intensities — 21 months
    Assessment of tolerability of study drug Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of exposure.

Trial sites (18)

FacilityCityRegionStatus
University Of Miami Miami Florida
University of Chicago Medical Center Chicago Illinois
The University of Kansas Clinical Research Ctr Fairway Kansas
Memorial Sloan Kettering Cancer Ctr New York New York
Oregon Health Sciences University Portland Oregon
Novartis Investigative Site Ghent Belgium
Novartis Investigative Site Beijing China
Novartis Investigative Site Shanghai China
Novartis Investigative Site Tianjin China
Novartis Investigative Site Créteil France
Novartis Investigative Site Marseille France
Novartis Investigative Site Tel Aviv Israel
Novartis Investigative Site Reggio Emilia RE
Novartis Investigative Site Kashiwa Chiba
Novartis Investigative Site Singapore Singapore
Novartis Investigative Site Singapore Singapore
Novartis Investigative Site Barcelona Spain
Novartis Investigative Site Barcelona Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05397496 on ClinicalTrials.gov ↗ ← All trials in Italy