Who is eligible for clinical trial NCT05397496?

Participants must meet the protocol's inclusion criteria for B-cell Non-Hodgkin Lymphoma (B-NHL). The stated age range is 18 Years to 100 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05397496 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-27

Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies (NCT05397496)

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

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Novartis Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (8 items).

Location: University Of Miami — Miami, Florida

Age range: 18 Years to 100 Years

🧪 Interventions in This Study

PIT565 (BIOLOGICAL)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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)

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (18 Sites)

University Of Miami — Miami, Florida
University of Chicago Medical Center — Chicago, Illinois
The University of Kansas Clinical Research Ctr — Fairway, Kansas
Memorial Sloan Kettering Cancer Ctr — New York, New York
Oregon Health Sciences University — Portland, Oregon
Novartis Investigative Site — Ghent,
Novartis Investigative Site — Beijing,
Novartis Investigative Site — Shanghai,
Novartis Investigative Site — Tianjin,
Novartis Investigative Site — Créteil,
Novartis Investigative Site — Marseille,
Novartis Investigative Site — Tel Aviv,
Novartis Investigative Site — Reggio Emilia, RE
Novartis Investigative Site — Kashiwa, Chiba
Novartis Investigative Site — Singapore,
Novartis Investigative Site — Singapore,
Novartis Investigative Site — Barcelona,
Novartis Investigative Site — Barcelona,

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All B-cell Non-Hodgkin Lymphoma (B-NHL) clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗