ClinicalTrials.gg
CompletedNCT03939026ALPHAUpdated Mar 2, 2026

Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma

A Phase 1 interventional study of ALLO-501 and ALLO-647 in Relapsed/Refractory Large B Cell Lymphoma and Relapsed/Refractory Follicular Lymphoma, sponsored by Allogene Therapeutics. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.

Primary conditionLymphoma, FollicularRegistry: RecurrenceReclassifiedWhy we changed it
Registry
Recurrence — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lymphoma, Follicular
Why
  1. Recurrence describes something many studies share rather than a condition a study is about.
  2. The study's listed conditions name Lymphoma, Follicular.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Allogene Therapeutics · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2021, 5 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

02

Conditions studied

  • Relapsed/Refractory Large B Cell Lymphoma
  • Relapsed/Refractory Follicular Lymphoma

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Keywords

  • CAR T
  • Cell Therapy
  • Allogeneic Cell Therapy
  • Cellular Immuno-therapy
  • AlloCAR T
  • ALLO-501
  • ALLO-647
  • LBCL
  • Lymphoma
  • Follicular Lymphoma
  • Large B-Cell Lymphoma
03

In context

Lymphoma, Follicular Reclassified

1,891 studies on the registry are indexed under Lymphoma, Follicular; 290 are open to participants now.

This study's enrollment of 50 is close to the median of 48 across 1,503 interventional studies indexed under Lymphoma, Follicular.

Browse Lymphoma, Follicular studies →

Lead sponsor

Allogene Therapeutics is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Compared within Lymphoma, Follicular, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
  • Relapse or disease after at least 2
  • At least 1 at time of screening.
  • Performance Status of 0 or 1.
  • Adequate hematological, renal, liver, pulmonary, and cardiac functions.

Exclusion criteria

Exclusion Criteria:

  • Current or history of central nervous system (CNS) lymphoma.
  • CNS dysfunction.
  • within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-647.
  • Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified cell therapy or adoptive T cell therapy
  • Systemic anticancer therapy within 2 weeks prior to study entry.
  • On-going treatment with agents.
  • Active acute or chronic (GvHD), or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment.
  • Any form of primary or acquired immunodeficiency (e.g., severe combined immunodeficiency disease).
  • Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy.
  • Patients unwilling to participate in an extended safety monitoring period
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    ALLO-647, ALLO-501

    Genetic: ALLO-501 · Biological: ALLO-647 · Drug: Fludarabine · Drug: Cyclophosphamide

Interventions

  • GeneticALLO-501

    ALLO-501 is an allogeneic CAR T cell therapy targeting CD19

  • BiologicalALLO-647

    ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

  • Chemotherapy for lymphodepletion

  • Chemotherapy for lymphodepletion

06

What researchers measure

Primary outcomes

  1. Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501

    Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion

    Time frame: 28 days

  2. Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501

    Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion

    Time frame: 33 days

07

Study locations

7 sites
  • Banner MD Anderson Cancer Center
    Gilbert, Arizona 85234, United States
  • Stanford University
    Stanford, California 94305, United States
  • Colorado Blood Cancer Institute
    Denver, Colorado 80218, United States
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • Norton Cancer Institute
    Louisville, Kentucky 40207, United States
  • St. Davids South Austin Medical Center
    Austin, Texas 78704, United States
  • MD Anderson
    Houston, Texas 77030, United States
08

References and documents

Publications

  • Locke FL, Munoz JL, Tees MT, Lekakis LJ, de Vos S, Nath R, Stevens DA, Malik SA, Shouse GP, Hamadani M, Oluwole OO, Perales MA, Miklos DB, Fisher PW, Feng A, Navale L, Le Gall JB, Neelapu SS. Allogeneic Chimeric Antigen Receptor T-Cell Products Cemacabtagene Ansegedleucel/ALLO-501 in Relapsed/Refractory Large B-Cell Lymphoma: Phase I Experience From the ALPHA2/ALPHA Clinical Studies. J Clin Oncol. 2025 May 10;43(14):1695-1705. doi: 10.1200/JCO-24-01933. Epub 2025 Feb 13. PubMed 39946666 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2019 to primary completion in Oct 2021, 29 months.

Of 84 industry-sponsored phase 1 interventional studies under Lymphoma, Follicular, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 71. This study's 29 months is below that.

Counting every sponsor, half of 173 studies reached it within 51 months; a quarter within 30 and three quarters within 80.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2019
First posted
May 6, 2019
StartActual
May 1, 2019
Primary completionActual
Oct 23, 2021
CompletionActual
Jan 28, 2025
Last update
Mar 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03939026
Lead sponsor
Allogene Therapeutics
Responsible party
Sponsor
First posted
May 6, 2019
Start date
May 1, 2019
Primary completion
Oct 23, 2021
Completion
Jan 28, 2025
Last update
Mar 2, 2026

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Anti-CD52 Monoclonal Antibody ALLO-647

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