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

A Phase I, Open-label, Multi-center Study of PIT565 in Patients With Relapsed and/or Refractory B-cell Malignancies Identifier: NCT05397496

Novartis Reference Number: CPIT565A12101

Last Update: Sep 22, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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).

B-cell Non-Hodgkin Lymphoma (B-NHL)
B-cell Acute Lymphoblastic Lymphoma (B-ALL)
Phase 1
Overall status 
Start date 
Sep 12, 2022
Completion date 
Jun 12, 2025
18 Years and older (Adult, Older Adult)


Intravenous (i.v.) infusion or Subcutaneous (s.c.) injection

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.

Study Locations

Novartis Investigative Site
Marseille, 13273
Novartis Investigative Site
Tel Aviv,


Novartis Pharmaceuticals
Novartis Pharmaceuticals

Have a question?

Call 1-888-669-6682 or email [email protected]