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

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 consentform

• 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 treatmenttherapies including an αCD20 monoclonal antibody containing chemotherapy combinationregimen

• Must have at least one bi-dimensionally measurable nodal lesion or onebi-dimensionally measurable extranodal lesion, as measured on positron emissiontomography-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 itsexcipients

• Contraindication to tocilizumab

• History of ongoing, chronic or recurrent infectious disease, or evidence oftuberculosis infection

• Malignant disease, other than that being treated in this study. Exceptions to thisexclusion include the following: malignancies that were treated curatively and havenot recurred within 2 years prior to study treatment; completely resected basal celland squamous cell skin cancers, and completely resected carcinoma in situ of anytype

• Active central nervous system (CNS) involvement by malignancy or presence ofsymptomatic CNS metastases, or CNS metastases that require local CNS-directedtherapy (such as radiotherapy or surgery), or increasing doses of corticosteroidswithin 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 requiringsystemic treatment or conditions not expected to recur

• Patients receiving systemic treatment with any immunosuppressive medication

Other protocol-defined inclusion/exclusion criteria may apply.