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

AbelZeta Inc.

Status and phase: Begins enrollment in 5 months; Phase 2

Conditions: Large B Cell Lymphoma; High Grade B Cell Lymphoma; Transformed Follicular Lymphoma (TFL); FL; HGBL With MYC and BCL2 and/or BCL6 Rearrangements; PMBCL; Diffuse Large B Cell Lymphoma (DLBCL); Primary Mediastinal B Cell Lymphoma; LBCL; HGBL; Relapse Diffuse Large B Cell Lymphoma

Treatments: Biological: Prizloncabtagene Autoleucel

Study type: Interventional

Funder types: Industry

Identifiers

NCT07875413

ABZT-121

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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. Diffuse large B-cell lymphoma/high-grade B-cell lymphoma with MYC and BCL2 rearrangements (DLBCL/HGBL-MYC/BCL2)
   5. High-grade B-cell lymphoma (HGBL), NOS
   6. 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)

4. 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.

5. Measurable disease per the Lugano 2014 Classification

Key Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

55 participants in 1 patient group

Prizlon-cel

Experimental group

Description:

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

Treatment:

Biological: Prizloncabtagene Autoleucel