Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT05397496

Active Not RecruitingPhase 1

Sponsor: Novartis Pharmaceuticals

Conditions: B-cell Non-Hodgkin Lymphoma (B-NHL), B-cell Acute Lymphoblastic Leukemia (B-ALL)

Interventions: PIT565

Countries: United States, Belgium, China, France, Israel, Italy, Japan, Singapore

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (18)
  • Miami, Florida, United States
  • Chicago, Illinois, United States
  • Fairway, Kansas, United States
  • New York, New York, United States
  • Portland, Oregon, United States
  • Ghent, Belgium
  • Beijing, China
  • Shanghai, China
  • Tianjin, China
  • Créteil, France
  • Marseille, France
  • Tel Aviv, Israel
  • Reggio Emilia, RE, Italy
  • Kashiwa, Chiba, Japan
  • Singapore, Singapore
  • Singapore, Singapore
  • Barcelona, Spain
  • Barcelona, Spain