Non Hodgkin Lymphoma Clinical Trial
Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies
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).
Full Description
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) will be identified for use in the expansion part based on the review of these data. The recommended dose (RD) will also be guided by the available information on pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity. The dose escalation will be guided by an adaptive Bayesian logistic regression model (BLRM) following the Escalation with Overdose Control (EWOC) principle.
Different schedules (once weekly (Q1W) or once every 2 weeks (Q2W) with and without priming dose) and routes of administrations (intravenous (i.v.) or subcutaneous (s.c.)) will be explored in the dose escalation groups.
The dose expansion will further explore the MTD(s) and/or RD(s) and the selected schedule(s) and route of administration(s) in the three patients' groups.
Eligibility Criteria
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.
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There are 11 Locations for this study
Miami Florida, 33136, United States More Info
Principal Investigator
New York New York, 10065, United States More Info
Principal Investigator
Gent , 9000, Belgium
Marseille , 13273, France
Tel Aviv , 63293, Israel
Bologna BO, 40138, Italy
Milano MI, 20133, Italy
Kashiwa Chiba, 277 8, Japan
Singapore , 16960, Singapore
Barcelona Catalunya, 08035, Spain
Barcelona Catalunya, 08036, Spain
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