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

NCT05397496 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: CPIT565A121012022-000367-45
• Study Type: interventional
• Target: 61
• Locations: 9 countries
• Sites: 18

Brief 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

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

Keywords

Phase I; Trispecific antibody; Non-Hodgkin lymphoma; Acute Lymphoblastic Leukemia; PIT565

Outcome Measures

Primary Outcomes (5)

• Incidence and severity of Dose Limiting Toxicities (DLTs)

  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.

  28 days or 35 days, depending on the dosing schedule

• Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Assessment of safety of study drug.

  21 months

• Frequency of dose interruptions

  Assessment of tolerability of study drug

  21 months

• Frequency of dose reductions

  Assessment of tolerability of study drug

  21 months

• Dose intensities

  Assessment of tolerability of study drug Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of exposure.

  21 months

Secondary Outcomes (12)

• Overall Response Rate (ORR)

  21 months

• Complete Response (CR) rate

  21 months

• Best Overall Response (BOR)

  21 months

• Duration Of Response (DOR)

  21 months

• Overall Survival (OS)

  33 months

Study Arms (5)

PIT565 Group A (dose escalation part)

EXPERIMENTAL

PIT565 in adult NHL patients for whom two or more lines of chemotherapy have failed and either having progressed (or relapsed) after autologous hematopoietic stem cell transplantation (HSCT), or being ineligible for or not consenting to the procedure

Biological: PIT565

PIT565 Group B (dose escalation part)

EXPERIMENTAL

PIT565 in adult R/R ALL patients.

Biological: PIT565

PIT565 Group A1 (dose expansion part)

EXPERIMENTAL

PIT565 Recommended dose 1 (RD1) in adult R/R large B-cell lymphoma (LBCL) (DLBCL, double/triple hit High-grade B-cell lymphoma (HGBCL), Primary mediastinal large B-cell lymphoma (PMBCL), Follicular lymphoma grade 3B (FL3B)) patients.

Biological: PIT565

PIT565 Group A2 (dose expansion part)

EXPERIMENTAL

PIT565 RD2 in adult R/R LBCL (DLBCL, double/triple hit HGBCL, PMBCL, FL3B) patients.

Biological: PIT565

PIT565 Group B1 (dose expansion part)

EXPERIMENTAL

PIT565 in adult R/R ALL patients.

Biological: PIT565

Interventions

PIT565 BIOLOGICAL

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

PIT565 Group A (dose escalation part); PIT565 Group A1 (dose expansion part); PIT565 Group A2 (dose expansion part); PIT565 Group B (dose escalation part); PIT565 Group B1 (dose expansion part)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (18)

University Of Miami

Miami, Florida, 33136, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

The University of Kansas Clinical Research Ctr

Fairway, Kansas, 66205, United States

Location

Memorial Sloan Kettering Cancer Ctr

New York, New York, 10065, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Beijing, 100730, China

Location

Novartis Investigative Site

Shanghai, 200032, China

Location

Novartis Investigative Site

Tianjin, 300020, China

Location

Novartis Investigative Site

Créteil, 94010, France

Location

Novartis Investigative Site

Marseille, 13273, France

Location

Novartis Investigative Site

Tel Aviv, 6423906, Israel

Location

Novartis Investigative Site

Reggio Emilia, RE, 42123, Italy

Location

Novartis Investigative Site

Kashiwa, Chiba, 2778577, Japan

Location

Novartis Investigative Site

Singapore, 119074, Singapore

Location

Novartis Investigative Site

Singapore, 169608, Singapore

Location

Novartis Investigative Site

Barcelona, 08035, Spain

Location

Novartis Investigative Site

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Burkitt Lymphoma; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: October 3, 2022
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): May 14, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3); BE (1); SG (2); US (5); FR (2); IT (1); ES (2); IL (1); JP (1)