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

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).

Conditions

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

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
B-cell Non-Hodgkin Lymphoma (B-NHL)
Intervention / Treatment

-

Contacts and Locations

Miami

University Of Miami, Miami, Florida, United States, 33136

New York

Memorial Sloan Kettering Cancer Ctr, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * Refractory or relapsed CD19-positive B-ALL
  • * Morphologic disease in the bone marrow (≥ 5% blasts)
  • * 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)

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Study Record Dates

2028-06-05