ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2022-10-03
Study Completion:2028-06-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05397496

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.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed informed consent must be obtained prior to participation in the study.
  2. * Male or female patients ≥18 years of age at the date of signing the informed consent form
  3. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  4. * Refractory or relapsed B-NHL
  5. * Must have relapsed after or failed to respond to at least two prior treatment therapies including an αCD20 monoclonal antibody containing chemotherapy combination regimen
  6. * 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
  7. * Refractory or relapsed CD19-positive B-ALL
  8. * Morphologic disease in the bone marrow (≥ 5% blasts)
  1. * History of severe hypersensitivity to any ingredient of the study treatment or its excipients
  2. * Contraindication to tocilizumab
  3. * History of ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection
  4. * 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
  5. * 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
  6. * 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
  7. * Patients receiving systemic treatment with any immunosuppressive medication

Contacts and Locations

Study Locations (Sites)

University Of Miami
Miami, Florida, 33136
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
The University of Kansas Clinical Research Ctr
Fairway, Kansas, 66205
United States
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10065
United States
Oregon Health Sciences University
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-03
Study Completion Date2028-06-05

Study Record Updates

Study Start Date2022-10-03
Study Completion Date2028-06-05

Terms related to this study

Keywords Provided by Researchers

  • Phase I
  • Trispecific antibody
  • Non-Hodgkin lymphoma
  • Acute Lymphoblastic Leukemia
  • PIT565

Additional Relevant MeSH Terms

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