Relapsed/Refractory Large B Cell LymphomaPhase 2EXPANDNCT05714345

Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy

A Phase 2 study testing ALLO-647, Fludarabine and Cyclophosphamide in people with Relapsed/Refractory Large B Cell Lymphoma, run by Allogene Therapeutics at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of the EXPAND study is to assess the safety and clinical efficacy of ALLO-647 combined with fludarabine and cyclophosphamide compared to fludarabine and cyclophosphamide alone in a lymphodepletion regimen prior to ALLO-501A CAR T therapy in adults with relapsed or refractory large B-cell lymphoma Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsed/Refractory Large B Cell Lymphoma
What is being tested?: ALLO-647, Fludarabine and Cyclophosphamide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 2 sitesin 2 countries
Study dates: 1 Nov 2023to 28 Oct 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse
Relapsed or refractory disease after at least 2 lines of chemotherapy
ECOG performance status 0 or 1
Absence of significant donor (product)-specific anti-HLA antibodies (DSA)
Adequate hematological, renal and liver function

Who cannot join

Active central nervous system involvement by malignancy
Autologous or allogeneic HSCT within last 6 months prior to lymphodepletion
Hypocellular bone marrow for age

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, 40202

Other trials in United States

Belgium1 site

Universitair Ziekenhuis Brussel
Brussels, 1090

Other trials in Belgium

About this study

Official title: A Randomized, Open-Label, Phase 2 Study Evaluating Lymphodepletion With ALLO-647, Fludarabine, and Cyclophosphamide, vs. Fludarabine and Cyclophosphamide Alone, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy

Conditions: Relapsed/Refractory Large B Cell Lymphoma
Being tested: ALLO-647, Fludarabine, Cyclophosphamide, ALLO-501A
Keywords: CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-501A, ALLO-647, LBCL, Lymphoma, Large B-Cell Lymphoma
Medical subject headings: Recurrence, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALLO-647Biological
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
FludarabineDrug
Chemotherapy for lymphodepletion
CyclophosphamideDrug
Chemotherapy for lymphodepletion
ALLO-501AGenetic
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19

Study groups in NCT05714345
Study group	Role	What they receive
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide	Experimental	ALLO-501A CAR T cells infused following lymphodepletion Receives: Biological: ALLO-647; Drug: Fludarabine; Drug: Cyclophosphamide; Genetic: ALLO-501A
Lymphodepletion with fludarabine and cyclophosphamide	Experimental	ALLO-501A CAR T cells infused following lymphodepletion Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Genetic: ALLO-501A

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival (PFS) of a Lymphodepletion Regimen Containing FCA vs FC Alone Per Independent Review Committee
To assess the clinical efficacy of ALLO-647 (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by PFS and assessed by Independent Review Committee (IRC) in subjects with R/R (Relapsed / Refractory) LBCL (Large B Cell Lymphoma).
In this study, PFS is defined as the time from randomization to disease progression, or relapse per the Lugano classification criteria (Cheson et al, 2014) as assessed by IRC or death.
Measured: Up to 60 months

Secondary outcomes (9)

Overall-response Rate (ORR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee
To assess the clinical efficacy of ALLO-647 as measured by ORR and assessed by Independent Review Committee (IRC) between treatment arms.
ORR is defined as best overall response (Complete Response and Partial Response, assessed using the Lugano classification criteria 2014; Cheson , et al, 2014) by IRC at any time up through commencement of new anti-cancer therapy or withdrawal of consent.
Measured: Up to 60 months
Event-Free-Survival (EFS) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee
To assess clinical efficacy of ALLO-647 with FC (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by Event-Free Survival (EFS) and assessed by Independent Review Committee (IRC) in subjects with R/R LBCL.
EFS is defined as the time from randomization to disease progression or relapse per the Lugano classification criteria 2014 as assessed by IRC, new anti-cancer therapy, or death.
Measured: Up to 60 months
Duration of Response (DOR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee
To characterize the efficacy of ALLO-647 as measured by Duration of Response (DOR) and assessed by Independent Review Committee (IRC) between treatment arms.
DOR is defined as time from the first observed response to disease progression or relapse (per IRC) or death.
Measured: Up to 60 months
Overall Survival (OS) of a Lymphodepletion Regimen Containing FCA vs FC
To characterize the efficacy of ALLO-647 as measured by OS, defined as the time from randomization to death.
Measured: Up to 60 months, study completion, or death, whichever occurs earlier. Specifically, OS was followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively.
Duration of Response, Event-Free Survival and Progression-Free Survival of a Lymphodepletion Regimen Containing FCA vs FC Based on Response Assessment Per Investigator Review
To characterize the efficacy of ALLO-647 as measured by response rate per investigator, Duration of Response (DOR), Event-Free Survival (EFS), Progression-Free Survival (PFS), assessed by investigator assessments between treatment arms.
DOR is defined as time from the first observed response to disease progression or relapse per investigator assessment, or death.
EFS is defined as the time from randomization to disease progression or relapse per investigator assessment per the Lugano classification criteria, new anti-cancer therapy, or death.
PFS is defined as time from the randomization to progression or relapse per investigator assessment per the Lugano classification criteria, or death.
Measured: Neither participant was a responder, therefore DOR was not followed. EFS and PFS were followed from first dose of study treatment until disease progression, subsequent anticancer therapy, or death. EFS and PFS were followed for 0.99 to 1.84 months.
Overall Response Rate of a Lymphodepletion Regimen Containing FCA vs FC Based on Response Assessment Per Investigator Review
To characterize the efficacy of ALLO-647 as measured by response rate per investigator, Overall Response Rate (ORR), and assessed by investigator assessments between treatment arms.
ORR in FCA vs FC alone per investigator assessment at any time up through commencement of new anti-cancer therapy or withdrawal of consent.
Measured: Overall Response Rate was followed until disease progression or subsequent anticancer therapy, whichever occurred earlier. Specifically, ORR was followed for 0.99 to 1.84 months for each participant in the FCA and FC arm, respectively.
Depth and Duration of a Lymphodepletion Regimen Containing FCA vs FC
To characterize the depth and duration of lymphodepletion with and without ALLO-647, as assessed by lymphocyte count.
Measured: From study treatment to study discontinuation, death, withdrawal of consent, or date of initiation of another anticancer therapy, whichever occurs first, for a maximum of 9 months. Only Day 28 lymphocyte counts are available for both participants.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
To evaluate the overall safety profile of ALLO-647 by comparing FCA lymphodepletion with FC lymphodepletion.
Measured: Up to 60 months, study completion, or death, whichever occurs earlier. TEAEs were followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively.
Incidence of ALLO-501A Related Treatment Emergent Adverse Events
To evaluate the overall safety profile of ALLO-501A following lymphodepletion.
Measured: Up to 60 months, study completion, or death, whichever occurs earlier. Related TEAEs were followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202328 Oct 2024

First posted6 Feb 2023
Study start1 Nov 2023
Primary completion20 Feb 2024
Study completion28 Oct 2024

Why it stopped: Terminated early for business reasons.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Relapsed/Refractory 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05714345
Sponsor's protocol ID: ALLO-647-201
Acronym: EXPAND
Status last verified: Feb 2026
First submitted: 8 Dec 2022
Last updated: 2 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
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Lymphoma, Waldenström Macroglobulinemia (WM)
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
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Not yet recruitingPhase 2/3
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All Relapsed/Refractory Large B Cell Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Phase 2 Study Evaluating Lymphodepletion With ALLO-647, Fludarabine, and Cyclophosphamide, vs. Fludarabine and Cyclophosphamide Alone, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy
ClinicalTrials.gov ID: NCT05714345
Acronym / sponsor ID: EXPAND / ALLO-647-201
Conditions: Relapsed/Refractory Large B Cell Lymphoma
Keywords: CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-501A, ALLO-647, LBCL
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated early for business reasons.
Enrolment: 2 participants (actual)
Lead sponsor: Allogene TherapeuticsIndustry (pharma, biotech, devices)
Study start: 1 Nov 2023 (actual)
Primary completion: 20 Feb 2024 (actual)
Study completion: 28 Oct 2024 (actual)
First posted: 6 Feb 2023 (actual)
Results: Posted 31 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide	Experimental	Biological: ALLO-647, Drug: Fludarabine, Drug: Cyclophosphamide, Genetic: ALLO-501AALLO-501A CAR T cells infused following lymphodepletion
Lymphodepletion with fludarabine and cyclophosphamide	Experimental	Drug: Fludarabine, Drug: Cyclophosphamide, Genetic: ALLO-501AALLO-501A CAR T cells infused following lymphodepletion

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse
Relapsed or refractory disease after at least 2 lines of chemotherapy
ECOG performance status 0 or 1
Absence of significant donor (product)-specific anti-HLA antibodies (DSA)
Adequate hematological, renal and liver function

Key exclusion criteria (3 listed)

Active central nervous system involvement by malignancy
Autologous or allogeneic HSCT within last 6 months prior to lymphodepletion
Hypocellular bone marrow for age

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
ALLO-647ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen	Biological	Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
FludarabineChemotherapy for lymphodepletion	Drug	Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide, Lymphodepletion with fludarabine and cyclophosphamide
CyclophosphamideChemotherapy for lymphodepletion	Drug	Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide, Lymphodepletion with fludarabine and cyclophosphamide
ALLO-501AALLO-501A is an allogeneic CAR T cell therapy targeting CD19	Genetic	Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide, Lymphodepletion with fludarabine and cyclophosphamide

Primary outcome

Progression-Free Survival (PFS) of a Lymphodepletion Regimen Containing FCA vs FC Alone Per Independent Review Committee
Time frame: Up to 60 months
To assess the clinical efficacy of ALLO-647 (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by PFS and assessed by Independent Review Committee (IRC) in subjects with R/R (Relapsed / Refractory) LBCL (Large B Cell Lymphoma). In this study, PFS is defined as the time from randomization to disease progression, or relapse per the Lugano classification criteria (Cheson et al, 2014) as assessed by IRC or death.

9 secondary outcomes

Overall-response Rate (ORR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee
Time frame: Up to 60 months
Event-Free-Survival (EFS) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee
Time frame: Up to 60 months
Duration of Response (DOR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee
Time frame: Up to 60 months
Overall Survival (OS) of a Lymphodepletion Regimen Containing FCA vs FC
Time frame: Up to 60 months, study completion, or death, whichever occurs earlier. Specifically, OS was followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively.
Duration of Response, Event-Free Survival and Progression-Free Survival of a Lymphodepletion Regimen Containing FCA vs FC Based on Response Assessment Per Investigator Review
Time frame: Neither participant was a responder, therefore DOR was not followed. EFS and PFS were followed from first dose of study treatment until disease progression, subsequent anticancer therapy, or death. EFS and PFS were followed for 0.99 to 1.84 months.
Overall Response Rate of a Lymphodepletion Regimen Containing FCA vs FC Based on Response Assessment Per Investigator Review
Time frame: Overall Response Rate was followed until disease progression or subsequent anticancer therapy, whichever occurred earlier. Specifically, ORR was followed for 0.99 to 1.84 months for each participant in the FCA and FC arm, respectively.
Depth and Duration of a Lymphodepletion Regimen Containing FCA vs FC
Time frame: From study treatment to study discontinuation, death, withdrawal of consent, or date of initiation of another anticancer therapy, whichever occurs first, for a maximum of 9 months. Only Day 28 lymphocyte counts are available for both participants.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 60 months, study completion, or death, whichever occurs earlier. TEAEs were followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively.
Incidence of ALLO-501A Related Treatment Emergent Adverse Events
Time frame: Up to 60 months, study completion, or death, whichever occurs earlier. Related TEAEs were followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively.

Results and safety

Results posted to the registry on 31 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA)	1	0
Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)	1	0

Primary outcome: Progression-Free Survival (PFS) of a Lymphodepletion Regimen Containing FCA vs FC Alone Per Independent Review Committee

Time frame: Up to 60 months. Median (95% Confidence Interval). Unit: Participants

Population analysed: Intent-to-Treat (ITT) Analysis Set: All randomized participants. Data does not exist as assessment of efficacy per Independent Review Committee was not performed.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA)	0 of 1 (0%)	1 of 1 (100%)	1 of 1
Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)	0 of 1 (0%)	1 of 1 (100%)	1 of 1

Limitations and caveats (from the sponsor): ALLO-647-201 (EXPAND) was a Phase 2 study that was terminated prior to completion for reasons not related to safety or efficacy concerns. No analyses of the baseline, disposition, safety, primary, secondary, nor exploratory endpoints were performed due to the limited enrollment and data collected during the study. Data were listed but not summarized.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Relapsed/Refractory Large B Cell Lymphoma

Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
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RecruitingPhase 1/2
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALLO-647, Fludarabine and Cyclophosphamide in people with Relapsed/Refractory Large B Cell Lymphoma, run by Allogene Therapeutics at 2 sites in 2 countries.

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 5 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: stopped early, as of the sponsor's last update on 2 Mar 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, Belgium. 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?

Yes. Results are posted in the registry (first posted 31 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) of a Lymphodepletion Regimen Containing FCA vs FC Alone Per Independent Review Committee (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05714345.

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 2 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.