Off-the-Shelf CAR t cells take on tough lymphomas

NCT ID NCT03939026

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a new type of cell therapy called ALLO-501, made from donor cells rather than the patient's own cells, in 50 adults with lymphoma that had come back or stopped responding to treatment. The therapy targets CD19, a protein on cancer cells, and was given after a short chemotherapy course to prepare the body. The main goals were to check safety and find the right dose, with early signs of effectiveness also being monitored.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ALLO-501 (a type of immune cell therapy made from donor cells, called allogeneic CAR T cells) and ALLO-647 (an antibody that helps prepare the body for the cell therapy)
What this could lead to
If this works, it could offer a ready-made, off-the-shelf cell therapy for people with hard-to-treat lymphomas, potentially avoiding the long wait and high cost of personalized CAR T treatments.
What could go wrong
This is an early, small Phase 1 trial focused on safety, so it is not yet proven to work. There are risks of serious side effects like cytokine release syndrome or nervous system problems, and the therapy may not control the cancer long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

50 people

The number who actually took part.

Started

May 2019

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma. * Relapse or refractory disease after at least 2 lines of chemotherapy * At least 1 measurable lesion at time of screening. * Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Adequate hematological, renal, liver, pulmonary, and cardiac functions. Exclusion Criteria: * Current or history of central nervous system (CNS) lymphoma. * Clinically significant CNS dysfunction. * ASCT 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 immunosuppressive agents. * Active acute or chronic graft versus host disease (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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • MD Anderson

    Houston, Texas, 77030, 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

  • Stanford University

    Stanford, California, 94305, United States

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