Testing PIT565 for patients with relapsed B-cell cancers
A Phase I, Open-label, Multi-center Study of PIT565 in Patients With Relapsed and/or Refractory B-cell Malignancies
PHASE1 · Novartis · NCT05397496
This study is testing a new treatment called PIT565 to see if it can be safe and effective for people with relapsed B-cell cancers like Non-Hodgkin lymphoma and acute lymphoblastic leukemia.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis (industry) |
| Drugs / interventions | tocilizumab, chemotherapy |
| Locations | 15 sites (Miami, Florida and 14 other locations) |
| Trial ID | NCT05397496 on ClinicalTrials.gov |
What this trial studies
This open-label, multicenter phase I study evaluates the safety and tolerability of PIT565 in patients with relapsed and/or refractory B-cell Non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia. The study involves a dose escalation phase to determine the maximum tolerated doses and recommended doses, followed by a dose expansion phase to further assess these doses and their administration schedules. An adaptive Bayesian logistic regression model will guide the dose escalation process, ensuring a thorough evaluation of safety and preliminary anti-tumor activity.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with relapsed or refractory B-cell Non-Hodgkin lymphoma or B-cell acute lymphoblastic leukemia who have failed prior therapies.
Not a fit: Patients with severe hypersensitivity to the study treatment or contraindications to tocilizumab may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with difficult-to-treat B-cell malignancies.
How similar studies have performed: Other studies involving trispecific antibodies have shown promise, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida and 14 other locations
- University Of Miami — Miami, Florida, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Ctr — New York, New York, United States (RECRUITING)
- Oregon Health Sciences University — Portland, Oregon, United States (RECRUITING)
- Novartis Investigative Site — Gent, Belgium (RECRUITING)
- Novartis Investigative Site — Shanghai, China (RECRUITING)
- Novartis Investigative Site — Creteil, France (RECRUITING)
- Novartis Investigative Site — Marseille, France (RECRUITING)
- Novartis Investigative Site — Tel Aviv, Israel (RECRUITING)
- Novartis Investigative Site — Bologna, BO, Italy (WITHDRAWN)
- Novartis Investigative Site — Milano, MI, Italy (WITHDRAWN)
- Novartis Investigative Site — Reggio Emilia, RE, Italy (RECRUITING)
- Novartis Investigative Site — Kashiwa, Chiba, Japan (RECRUITING)
- Novartis Investigative Site — Singapore, Singapore (RECRUITING)
- Novartis Investigative Site — Barcelona, Catalunya, Spain (RECRUITING)
- Novartis Investigative Site — Barcelona, Catalunya, Spain (RECRUITING)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: B-cell Non-Hodgkin Lymphoma, B-cell Acute Lymphoblastic Leukemia, Phase I, Trispecific antibody, Non-Hodgkin lymphoma, Acute Lymphoblastic Leukemia, PIT565