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.
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.
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