Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies
B-cell Non-Hodgkin Lymphoma (B-NHL), B-cell Acute Lymphoblastic Leukemia (B-ALL)
About this trial
This is an interventional treatment trial for B-cell Non-Hodgkin Lymphoma (B-NHL) focused on measuring Phase I, Trispecific antibody, Non-Hodgkin lymphoma, Acute Lymphoblastic Leukemia, PIT565
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.
Sites / Locations
- Memorial Sloan Kettering Cancer CenterRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
PIT565 Group A (dose escalation part)
PIT565 Group B (dose escalation part)
PIT565 Group A1 (dose expansion part)
PIT565 Group A2 (dose expansion part)
PIT565 Group B1 (dose expansion part)
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
PIT565 in adult R/R ALL patients
PIT565 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 who did not receive CD19-directed CAR-T therapy
PIT565 in adult R/R LBCL (DLBCL, double/triple hit HGBCL, PMBCL, FL3B) patients who received CD19-directed CAR-T therapy
PIT565 in adult R/R ALL patients