Status:
RECRUITING
Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
B-cell Non-Hodgkin Lymphoma (B-NHL)
B-cell Acute Lymphoblastic Leukemia (B-ALL)
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
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 do...
Detailed Description
This is an open-label, multicenter, phase I study of PIT565 in patients with R/R B-NHL and R/R B-ALL. The study comprises a dose escalation part of PIT565 in two independent groups (group A: R/R B-NH...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 5 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05397496
Start Date
October 3 2022
End Date
June 5 2028
Last Update
October 20 2025
Active Locations (21)
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1
University Of Miami
Miami, Florida, United States, 33136
2
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
3
The University of Kansas Clinical Research Ctr
Fairway, Kansas, United States, 66205
4
Memorial Sloan Kettering Cancer Ctr
New York, New York, United States, 10065