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

Launched by NOVARTIS PHARMACEUTICALS · May 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called PIT565 for patients with certain types of blood cancers, specifically relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL) and B-cell Acute Lymphoblastic Leukemia (B-ALL). The main goal is to find out how safe PIT565 is, how well it can be tolerated, and to determine the best dose and way to administer it. This trial is currently recruiting participants aged 18 and older who have not responded to at least two previous treatments for their cancer.

To be eligible for this study, participants must have measurable cancer that has returned or has not improved after prior therapies. They should also have a performance status that indicates they are relatively well and able to participate in the trial. Participants will receive the treatment and be closely monitored for any side effects and how their cancer responds. This trial is important as it aims to provide more effective options for patients with challenging blood cancers.

Gender

ALL

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 protocol-defined inclusion/exclusion criteria may apply.