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 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.