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A Phase I, Open-label, Multi-center Study of PIT565 in Patients With Relapsed and/or Refractory B-cell Malignancies


Description

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).This is an open-label, multicenter, phase I study of PIT565 in patients with R/R B-NHL and R/R B-ALL. The study comprises a dose escalation part of PIT565 in two independent groups (group A: R/R B-NHL and B: R/R B-ALL) and a dose expansion part in three independent groups (relapsed and/or refractory large B-cell lymphoma (R/R LBCL) who received CAR-T therapy (A2) or not (A1), and R/R B-ALL (B1)). During the dose escalation, the safety (including the dose-dose limiting toxicity (DLT) relationship) and tolerability of PIT565 will be assessed, and schedule(s), route(s) of administration and dose(s

Trial Eligibility

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 than steroids as described above) Other protocol-defined inclusion/exclusion criteria may apply.

Study Info

Organization

Novartis


Primary Outcome

Incidence and severity of Dose Limiting Toxicities (DLTs)


Outcome Timeframe 28 days or 35 days, depending on the dosing schedule

NCTID NCT05397496

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2022-10-03

Completion Date 2027-06-07

Enrollment Target 140

Interventions

BIOLOGICAL PIT565

Locations Recruiting

University Of Miami .

United States, Florida, Miami


Memorial Sloan Kettering Cancer Ctr .

United States, New York, New York


Novartis Investigative Site

Belgium, Gent


Novartis Investigative Site

France, Creteil


Novartis Investigative Site

France, Marseille


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