Experimental donor CAR-T therapy tested in lymphoma – trial halted early
NCT ID NCT06256484
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a new therapy called ATA3219, which uses immune cells from a healthy donor to attack cancer cells in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The study aimed to check safety and see if the treatment works, but it was stopped early after enrolling only one participant. Because the trial was so small, we cannot draw any conclusions about how well this therapy might work.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ATA3219 (a type of immune cell therapy called CAR-T, made from donor cells)
- What this could lead to
- If it works, this could offer a new treatment option for people with hard-to-treat B-cell lymphoma who have run out of standard therapies.
- What could go wrong
- This was a very early, small Phase 1 trial that was terminated after enrolling only 1 person, so we have very little data. The therapy may cause serious side effects like cytokine release syndrome or nervous system problems.
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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1 person
The number who actually took part.
- Started
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Sep 2024
- Finished
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Mar 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
-
18 to 120 years
- 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: * Histologically confirmed, R/R, B-cell NHL according to the 2022 revision of the World Health Organization classification of lymphoid neoplasms \[Alaggio 2022\] defined as any of the following: 1. LBCL 2. FL Grade 3b 3. MCL * The following criteria apply for details of prior treatment/therapy: R/R to at least 2 lines of therapy; if the most recent line of therapy was autologous hematologic cell transplant (HCT), relapse within 12 months of the transplant. * Measurable disease by scan (diagnostic positron emission tomography-positive and/or computed tomography-measurable) as per Lugano Classification \[Cheson 2014\]. Magnetic resonance imaging may be used when computed tomography with contrast is contraindicated or when mandated by local practice. * If sufficient archival material is not available from the latest relapse, a new tumor biopsy is required any time during screening, prior to conditioning chemotherapy. * Participants who have received prior CD19-directed therapy as the prior line of therapy: 1. must have achieved either a CR or partial response as a best response and maintained the response for ≥ 3 months after receiving CD19-directed treatment, and 2. must still have CD19+ disease as determined by a local laboratory. * Eastern Cooperative Oncology Group performance status ≤ 2 * Adequate organ function * Written informed consent as per protocol. * Participants are able to commit to the inpatient portion of the study, encompassing conditioning (if per the institution's standard practice), and frequent monitoring during Days 1-15, as well as remain within 1 hour travel time of the clinical site for 28 days after each infusion. Exclusion Criteria: * History of a human immunodeficiency virus infection or acute or chronic active hepatitis B or C infection. * History or presence of clinically relevant central nervous system (CNS) pathology. * Unresolved Grade 1-2 Immune effector cell-associated neurotoxicity syndrome (ICANS) or experienced Grade 3-4 ICANS from prior chimeric antigen receptor T-cell. * Unresolved graft-versus-host disease (GvHD) or Grade 3-4 acute GvHD from any prior therapy or moderate to severe chronic GvHD from any prior therapy. * History of any one of the following cardiovascular conditions: class III or IV heart failure as defined by the New York Heart Association \[The Criteria Committee of the New York Heart Association 1994\], cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically meaningful cardiac disease, within the past 6 months of study informed consent. * History of malignancies, other than R/R NHL, unless the participant has been disease-free for ≥ 1 year (certain noninvasive malignancies are allowed). * Active primary, CNS-only, or systemic plus CNS involvement by lymphoma, unless the CNS involvement has been effectively treated. * Active autoimmune disorders or inflammatory conditions that require systemic immunosuppressive therapies, including therapeutic doses of steroids. * Has received prior allogeneic HCT or prior solid organ transplant. * Systemic bacterial, viral, fungal, or other infection that is untreated or unresponsive to appropriate treatment (or requires IV antibiotics at enrollment); participants must be afebrile for ≥ 48 hours. Prophylactic antibiotics, antivirals, and antifungals are permitted. * Concurrent serious uncontrolled or unresolved medical condition, including any laboratory abnormality or psychiatric illness. * The following therapies within defined periods prior to the conditioning regimen: therapeutic doses of corticosteroids (\> 0.5 mg/kg/day of prednisone or equivalent), lymphodepleting chemotherapeutic agents, live attenuated vaccines, prior systemic cancer therapy, investigational agents, including approved drugs being used off label, autologous HCT, donor lymphocyte infusions, radiation, alemtuzumab. * Female who is breastfeeding or pregnant. * Inability or unwillingness to comply with study procedures. * Unwilling to use protocol specified contraceptive methods. * Life expectancy of ≤ 8 weeks. * For participants being considered for retreatment: had a DLT with prior ATA3219 dose.
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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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AdventHealth Cancer Institute
Orlando, Florida, 32804, United States
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Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
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Norton Cancer Institute - Saint Matthews
Louisville, Kentucky, 40207, United States
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Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
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Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, 19107, United States
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University of Virgina
Charlottesville, Virginia, 22908, United States
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