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

NCT07875413 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ABZT-121
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief 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.

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

Keywords

LBCL; Large B Cell Lymphoma; Diffuse Large B Cell Lymphoma; CAR-T cell; CAR T-cell therapy; CAR T; CD19; CD20; Lymphoma; PBMCL; cell therapy; chimeric antigen receptor T-cell therapy; chimeric antigen receptor; Car-T; Follicular Lymphoma; TFL; MYC; BCL2; HGBL; High Grade B Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR)

  ORR, including CR rate and PR rate according to the Lugano Criteria 2014

  Through Month 24

• Incidence and severity of adverse events (AEs)

  Evaluate the incidence, severity, and relationship of adverse events following C-CAR168 infusion, graded according to NCI CTCAE Version 6.0.

  Through Month 24

Secondary Outcomes (9)

• Duration of Response (DOR)

  Through Month 24

• Complete Response Rate

  Through Month 24

• Best Overall Response (BOR)

  Through Month 24

• Time to Response

  Through Month 24

• Progression Free Survival (PFS)

  Through Month 24

Study Arms (1)

Prizlon-cel

EXPERIMENTAL

Participants will receive: • Leukapheresis • Fludarabine • Cyclophosphamide • Single intravenous infusion of Prizlon-cel.

Biological: Prizloncabtagene Autoleucel

Interventions

Prizloncabtagene Autoleucel BIOLOGICAL

An Autologous anti-CD19/CD20 chimeric antigen receptor T-cell therapy

Prizlon-cel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify if:

• Prior allogeneic hematopoietic stem cell transplantation (HSCT)
• ASCT within 12 weeks of leukapheresis
• Prior treatment with any investigational CAR T-cell therapy

Sponsors & Collaborators

• AbelZeta Inc.: lead

Study Sites (2)

Research Site

Gilbert, Arizona, 85234, United States

Location

Research Site

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yihong Yao, PhD

  AbelZeta Inc.

  STUDY DIRECTOR

Central Study Contacts

Kirstin Liechty, Head of Clinical Operations

CONTACT

267-566-6081; kirstin.liechty@abelzeta.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled participants undergo leukapheresis, and then receive lymphodepleting chemotherapy followed by a single infusion of Prizlon-cel.

Study Record Dates

• First Submitted: October 6, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)