Off-the-Shelf cell therapy takes on tough lymphoma
NCT ID NCT07248163
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a one-time treatment using universal (off-the-shelf) CAR-T cells that target CD19, a protein on cancer cells. It is for adults with relapsed or refractory B-cell non-Hodgkin lymphoma who have few options left. The main goal is to check safety and find the right dose, with up to 6 participants.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Willing to participate in this clinical study and sign an informed consent form; 2. Age ≥ 18 years old; 3. Estimated survival time ≥ 3 months; 4. At least one measurable lesion; 5. CD19 positively expressed; 6. ECOG score 0-1; 7. Hematology, coagulation and biochemistry parameters meeting the requirements; 8. LVEF ≥ 55%; 9. No severe pulmonary disorders; Exclusion Criteria: 1. Pregnant or lactating women; 2. Subjects who previously received allogeneic cell therapies, including allogeneic stem cell transplant; 3. Subjects who previously received anti-CD19 targeted therapy; 4. Prior treatment with any CAR-T cell product or other genetically modified T cell therapies; 5. History of Richter's transformation of chronic lymphocytic leukemia (CLL); 6. Presence of uncontrollable fungal, bacterial, viral, or other infections requiring systemic therapy; 7. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis test positive; 8. Severe mental disorders; history of CNS disorders (e.g., epileptic seizure, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any CNS-involved autoimmune disorders); 9. Active autoimmune disorders requiring immunotherapy, including but not limited to end organ damages caused by autoimmune disorders (e.g., Crohn's disease, rheumatoid arthritis, and systemic lupus erythematosus) in the past 2 years, or requiring systemic application of immunosuppressive drugs or other drugs for systemic control of diseases; 10. Primary immunodeficiency; 11. History of other malignancies; 12. Patients with severe cardiovascular disorders; 13. Any circumstances that possibly increase the risk of subjects or interfere with the study results as judged by the investigator.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghi Tongji Hospital (Tongji Hospital of Tongji University)
RECRUITINGShanghai, 620000, China
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Other studies related to the condition(s) this trial covers.
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