Clinical Research Directory

A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma

The researchers are doing this study to find out if the study treatment is an effective treatment that causes few or mild side effects in people with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), or transformed lymphoma. The treatment being tested in this study is glofitamab, polatuzumab, and obinutuzumab in combination with standard treatment (the combination of rituximab, cyclophosphamide, doxorubicin, and prednisone, or R-miniCHP).

Prospective ctDNA Testing in Large B-Cell Lymphoma

Diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) are aggressive lymphomas commonly treated with first-line immunochemotherapy. Some patients experience disease progression or relapse despite treatment. PET/CT is used to assess treatment response, but it may not identify small amounts of residual lymphoma. Circulating tumor DNA (ctDNA) consists of tumor-derived DNA fragments detectable in blood. This prospective observational study will use PhasED-seq to assess plasma ctDNA before, during, and after first-line therapy in approximately 100 patients with newly diagnosed DLBCL or HGBL. The primary objective is to evaluate the association between ctDNA status approximately 8 weeks after completion of first-line therapy and subsequent progression-free survival. Additional analyses will examine overall survival, earlier ctDNA findings, and baseline tumor molecular subtypes. PET/CT findings will provide complementary information for exploratory analyses. The findings may inform future studies of response-adapted treatment.

Prizloncabtagene Autoleucel (Prizlon-cel) for the Treatment of Relapsed or Refractory Large B-cell Lymphoma Post FDA Approved CAR T-cell Therapy

This Phase 2, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of Prizloncel, an anti-CD19/CD20 chimeric antigen receptor T cells following lymphodepleting chemotherapy in participants with relapsed/refractory (r/r) diffuse large B-cell lymphoma post FDA approved, commercially available CAR T-cell therapy Approximately 50 participants will undergo leukapheresis, lymphodepletion with fludarabine and cyclophosphamide, and infusion of Prizlon-cel. Participants will be followed for 24 months (approximately 2 years) to evaluate efficacy, safety, CAR T-cell persistence, pharmacokinetics/pharmacodynamics, and biomarkers. Long-term safety follow-up for gene therapy-related events will continue for up to 15 years following CAR T-cell infusion.

A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies

This study is a Phase 1/2 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV400. The study will enroll patients with relapsed/refractory B-cell malignancies, including large B-cell lymphoma (LBCL).

Long-term Study to Evaluate Safety and Persistence of GF-CART01

The goal of this observational study is to learn about the long-term safety of GF-CART01 after cell infusion up to 15 years.

Neurocognitive Assessment in Adults Undergoing CD19 Targeted CAR-T Cell Therapy

This is an observational, multicenter, prospective cohort study including patients treated with CAR-T in Italian centers. Patients eligible for enrollment in the study will be consecutively included in Italian FIL centers. A longitudinal survey will be carried out by collecting patients' data before starting CAR-T (T0) and after 6 (T1), 12 (T2) and 24 (T3) months after CAR-T infusion.