What this study is
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.
What's being tested
- Prizloncabtagene Autoleucel
Intervention · BIOLOGICAL
An Autologous anti-CD19/CD20 chimeric antigen receptor T-cell therapy
Study details
- Official title
- 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
- Sponsor
- AbelZeta Inc.
- Conditions
- Large B Cell Lymphoma · LBCL · Diffuse Large B Cell Lymphoma (DLBCL) · Relapse Diffuse Large B Cell Lymphoma · High Grade B Cell Lymphoma · FL · HGBL · Transformed Follicular Lymphoma (TFL) · Primary Mediastinal B Cell Lymphoma · PMBCL · HGBL With MYC and BCL2 and/or BCL6 Rearrangements
- Enrolling
- 55 people
- Starts
- 2027-05
- Est. completion
- 2030-12
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Able to sign and date the Informed Consent Form (ICF)
- ≥18 years of age, at the time of signing informed consent
- Diagnosis of B-cell non-Hodgkin lymphoma (B-NHL), including the following neoplasms as defined by the 2022 WHO classification of lymphoid neoplasms:; Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); Primary mediastinal large B-cell lymphoma (PMBCL); Transformed follicular lymphoma (tFL) (Pathology report is required to clarify DLBCL rather than follicular lymphoma (FL) with local/minor progression to DLBCL); Diffuse large B-cell lymphoma/high-grade B-cell lymphoma with MYC and BCL2 rearrangements (DLBCL/HGBL-MYC/BCL2); High-grade B-cell lymphoma (HGBL), NOS; Follicular large B-cell lymphoma (FLBL) (At least 2 pathological diagnoses of follicular lymphoma grade 3B [FL3b] at different times are required, and the most recent pathology used for screening is FL3b or FLBL)
- R/R disease after ≥2 lines of standard therapy, including FDA approved, commercially available CAR T-cell therapy for at least 3 months since previous CAR T-cell therapy treatment.
- Measurable disease per the Lugano 2014 Classification
You can't join if
- Prior allogeneic hematopoietic stem cell transplantation (HSCT)
- ASCT within 12 weeks of leukapheresis
- Prior treatment with any investigational CAR T-cell therapy
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (2)
2 openResearch Site
Gilbert, Arizona, United States
Research Site
La Jolla, California, United States
Study team
Sponsor
AbelZeta Inc.
Study ID ABZT-121
Study director
Yihong Yao, PhD
AbelZeta Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.