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Not yet recruitingNCT07875413Updated Oct 15, 2026

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

A Phase 2 interventional study of Prizloncabtagene Autoleucel in Large B Cell Lymphoma, LBCL and Diffuse Large B Cell Lymphoma (DLBCL), sponsored by AbelZeta Inc.. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by AbelZeta Inc. · Phase 2, Interventional, and Treatment

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Lymphoma, Large B-Cell, Diffuse

1,432 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 359 are open to participants now.

This study's planned enrollment of 55 is above the median of 47 across 1,214 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.

Browse Lymphoma, Large B-Cell, Diffuse studies →

Lead sponsor

AbelZeta Inc. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • Experimental
    Prizlon-cel

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

    Biological: Prizloncabtagene Autoleucel

Interventions

06

What researchers measure

Primary outcomes

  1. Overall Response Rate (ORR)

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

    Time frame: Through Month 24

  2. 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.

    Time frame: Through Month 24

Secondary outcomes

  1. Duration of Response (DOR)

    Duration of response from first objective response

    Time frame: Through Month 24

  2. Complete Response Rate

    Percentage of participants that received Prizlon-cel that achieve a complete response

    Time frame: Through Month 24

  3. Best Overall Response (BOR)

    Best overall response of participants that received Prizlon-cel

    Time frame: Through Month 24

  4. Time to Response

    Time of first objective response from Prizlon-cel infusion

    Time frame: Through Month 24

  5. Progression Free Survival (PFS)

    Time from enrollment until progression, relapse or death

    Time frame: Through Month 24

  6. Overall Survival (OS)

    Time from date of enrollment to the date of death from any cause.

    Time frame: Through Month 24

  7. Quantitative polymerase chain reaction (qPCR) to determine maximum plasma concentration of Prizloncel post infusion

    Characterize CAR T-cell expansion and persistence using qPCR to measure maximum plasma concentration (Cmax) after Prizloncel infusion

    Time frame: Through Month 24

  8. Area under the Curve (AUC) utilizing flow cytometry to determine Prizloncel persistence

    Characterize T-cell expansion and persistence utilizing flow cytometry to determine the AUC of Prizloncel in peripheral blood

    Time frame: Through Month 24

  9. Changes in CD19/CD20-positive cells in peripheral blood after Prizlon-cel infusion

    Changes in CD19/CD20-positive cells in peripheral blood after Prizlon-cel infusion utilizing flow cytometry

    Time frame: Through Month 24

07

Study locations

2 sites
  • Research Site
    Gilbert, Arizona 85234, United States
  • Research Site
    La Jolla, California 92037, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07875413
Lead sponsor
AbelZeta Inc.
Responsible party
Sponsor
First posted
Oct 15, 2026
Start date
May 2027 (estimated)
Primary completion
Jun 2029 (estimated)
Completion
Dec 2030 (estimated)
Last update
Oct 15, 2026

Study contacts

Kirstin Liechty, Head of Clinical Operations
Contact
kirstin.liechty@abelzeta.com
267-566-6081
Yihong Yao, PhD
study director · AbelZeta Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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