Large B Cell LymphomaPhase 2NCT07875413
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 study testing Prizloncabtagene Autoleucel in people with Large B Cell Lymphoma and LBCL, run by AbelZeta Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large B Cell Lymphoma, LBCL, Diffuse Large B Cell Lymphoma (DLBCL)
- What is being tested?
- Prizloncabtagene Autoleucel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2027to Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- Prior allogeneic hematopoietic stem cell transplantation (HSCT)
- ASCT within 12 weeks of leukapheresis
- Prior treatment with any investigational CAR T-cell therapy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Research Site
Gilbert, Arizona, 85234
Research Site
La Jolla, California, 92037
About this study
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
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
- Being tested
- Prizloncabtagene Autoleucel
- 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
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prizloncabtagene AutoleucelBiological
An Autologous anti-CD19/CD20 chimeric antigen receptor T-cell therapy
| Study group | Role | What they receive |
|---|---|---|
| Prizlon-cel | Experimental | Participants will receive: • Leukapheresis • Fludarabine • Cyclophosphamide • Single intravenous infusion of Prizlon-cel. Receives: Biological: Prizloncabtagene Autoleucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR, including CR rate and PR rate according to the Lugano Criteria 2014
Measured: 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.
Measured: Through Month 24
Secondary outcomes (9)
Duration of Response (DOR)
Duration of response from first objective response
Measured: Through Month 24
Complete Response Rate
Percentage of participants that received Prizlon-cel that achieve a complete response
Measured: Through Month 24
Best Overall Response (BOR)
Best overall response of participants that received Prizlon-cel
Measured: Through Month 24
Time to Response
Time of first objective response from Prizlon-cel infusion
Measured: Through Month 24
Progression Free Survival (PFS)
Time from enrollment until progression, relapse or death
Measured: Through Month 24
Overall Survival (OS)
Time from date of enrollment to the date of death from any cause.
Measured: Through Month 24
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
Measured: Through Month 24
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
Measured: Through Month 24
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
Measured: Through Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startMay 2027 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants undergo leukapheresis, and then receive lymphodepleting chemotherapy followed by a single infusion of Prizlon-cel.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbelZeta Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yihong Yao, PhD, Study director, AbelZeta Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875413
- Sponsor's protocol ID
- ABZT-121
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07875413
- Acronym / sponsor ID
- ABZT-121
- Conditions
- Large B Cell Lymphoma, LBCL, Diffuse Large B Cell Lymphoma (DLBCL), Relapse Diffuse Large B Cell Lymphoma, High Grade B Cell Lymphoma, FL
- Keywords
- LBCL, Large B Cell Lymphoma, Diffuse Large B Cell Lymphoma, CAR-T cell, CAR T-cell therapy, CAR T, CD19, CD20
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- AbelZeta Inc.Industry (pharma, biotech, devices)
- Study start
- May 2027 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants undergo leukapheresis, and then receive lymphodepleting chemotherapy followed by a single infusion of Prizlon-cel.
| Arm | Type | Receives |
|---|---|---|
| Prizlon-cel | Experimental | Biological: Prizloncabtagene AutoleucelParticipants will receive: • Leukapheresis • Fludarabine • Cyclophosphamide • Single intravenous infusion of Prizlon-cel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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
Key exclusion criteria (3 listed)
- Prior allogeneic hematopoietic stem cell transplantation (HSCT)
- ASCT within 12 weeks of leukapheresis
- Prior treatment with any investigational CAR T-cell therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prizloncabtagene AutoleucelAn Autologous anti-CD19/CD20 chimeric antigen receptor T-cell therapy | Biological | Prizlon-cel |
Primary outcome
Overall Response Rate (ORR)
Time frame: Through Month 24
ORR, including CR rate and PR rate according to the Lugano Criteria 2014
Incidence and severity of adverse events (AEs)
Time frame: Through Month 24
Evaluate the incidence, severity, and relationship of adverse events following C-CAR168 infusion, graded according to NCI CTCAE Version 6.0.
9 secondary outcomes
Duration of Response (DOR)
Time frame: Through Month 24
Complete Response Rate
Time frame: Through Month 24
Best Overall Response (BOR)
Time frame: Through Month 24
Time to Response
Time frame: Through Month 24
Progression Free Survival (PFS)
Time frame: Through Month 24
Overall Survival (OS)
Time frame: Through Month 24
Quantitative polymerase chain reaction (qPCR) to determine maximum plasma concentration of Prizloncel post infusion
Time frame: Through Month 24
Area under the Curve (AUC) utilizing flow cytometry to determine Prizloncel persistence
Time frame: Through Month 24
Changes in CD19/CD20-positive cells in peripheral blood after Prizlon-cel infusion
Time frame: Through Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yihong Yao, PhD study director
AbelZeta Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prizloncabtagene Autoleucel in people with Large B Cell Lymphoma and LBCL, run by AbelZeta Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirstin Liechty, Head of Clinical Operations (267-566-6081, kirstin.liechty@abelzeta.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Through Month 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.