Off-the-Shelf CAR t cells take on tough lymphomas
NCT ID NCT03939026
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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50 people
The number who actually took part.
- Started
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May 2019
- Finished
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Jan 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
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Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
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MD Anderson
Houston, Texas, 77030, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Norton Cancer Institute
Louisville, Kentucky, 40207, United States
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St. Davids South Austin Medical Center
Austin, Texas, 78704, United States
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Stanford University
Stanford, California, 94305, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New combo therapy aims to boost remission in Hard-to-Treat lymphoma
- Automated CAR-T therapy shows promise for Tough-to-Treat lymphoma
- New hope for lymphoma patients: glofitamab combo faces standard care in trial
- Double-Barreled attack: CAR-T plus stem cell transplant takes on aggressive lymphoma
- Affordable CAR-T breakthrough: academic therapy offers new hope for blood cancer patients
- Experimental donor CAR-T therapy tested in lymphoma – trial halted early