A Multi-center, Phase 2 Clinical Study of an Autologous Anti-CD19/CD20 Chimeric Antigen Receptor T-Cell Therapy, Prizloncabtagene Autoleucel (Prizlon-cel), for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma
AbelZeta Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria 1. Able to sign and date the Informed Consent Form (ICF) 2. ≥18 years of age, at the time of signing informed consent 3. Diagnosis of B-cell non-Hodgkin lymphoma (B-NHL), including the following neoplasms as defined by the 2022 WHO classification of lymphoid neoplasms: 1. Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) 2. Primary mediastinal large B-cell lymphoma (PMBCL) 3. Transformed follicular lymphoma (tFL) (Pathology report is required to clarify DLBCL rather than follicular lymphoma (FL) with local/minor progression to DLBCL) 4. D…
Interventions
- BiologicalPrizloncabtagene Autoleucel
An Autologous anti-CD19/CD20 chimeric antigen receptor T-cell therapy
Locations (2)
- Research SiteGilbert, Arizona
- Research SiteLa Jolla, California