Double-Pronged cell therapy takes on tough lymphoma
NCT ID NCT07344818
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing a new type of cell therapy that uses a patient's own immune cells, engineered to attack two targets (CD19 and CD20) on lymphoma cells. It aims to see if this approach is safe for people with aggressive B-cell lymphoma that has come back or not responded to prior treatments. The study will enroll 18 adults and is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD19 and CD20 dual-target CAR-T cells (a type of immune cell therapy made from the patient's own blood)
- What this could lead to
- If it works, this could point toward a new treatment option for people with aggressive B-cell lymphoma that has not responded to standard therapy.
- What could go wrong
- This is a very early, small trial (18 people) focused on safety, not yet on effectiveness. The therapy may cause serious side effects or fail to 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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: 1. The subject or his/her legal guardian is able to understand and voluntarily sign the informed consent form (ICF). 2. Male or female subjects aged ≥18 years at the time of signing the ICF. 3. An expected life expectancy of at least 12 weeks. 4. An ECOG performance status of 0-2 at the time of signing the ICF. 5. A diagnosis of relapsed or refractory aggressive B-cell lymphoma at the time of signing the ICF. Subjects must have previously received treatment with anthracycline-containing chemotherapy and rituximab (or other CD20-targeted agents), and must have experienced relapse or progression after at least two prior lines of therapy or autologous hematopoietic stem cell transplantation (ASCT). 6. Presence of measurable positive lesions as defined by the Lugano criteria. 7. Lymphoma lesions confirmed by biopsy to screening demonstrating expression of CD19 and/or CD20. 8. Adequate major organ function. 9. contraception. Exclusion Criteria: 1. Lymphoma involving only the central nervous system (CNS) (except for secondary CNS lymphoma). 2. History of CNS disorders. 3. History of autoimmune disease requiring systemic immunosuppressive therapy within 4 weeks prior to signing the ICF. 4. Presence of any uncontrolled active infection at the time of signing the ICF or within 2 weeks prior to leukapheresis, requiring antibiotic, antiviral, or antifungal treatment. 5. Evidence of active infection, including: HBV DNA、Positive anti-HCV antibody with detectable HCV RNA、Positive HIV antibody、Positive cytomegalovirus (CMV) DNA、Positive Epstein-Barr virus (EBV) DNA、Positive both treponemal-specific and non-specific serologic tests for syphilis. 6. Clinically significant cardiovascular disease. 7. Known hypersensitivity to any component of the investigational products used in this study. 8. Receipt of any disease-related investigational therapy or other systemic antitumor therapy prior to leukapheresis and within 5 half-lives of the drug. 9. Requirement for systemic corticosteroids (at a dose equivalent to ≥20 mg/day of prednisone) or other immunosuppressive agents within 2 weeks prior to signing the ICF, within 2 weeks prior to leukapheresis, or during the study. 10. Major surgery (excluding routine biopsy) within 4 weeks prior to signing the ICF, or planned major surgery during the study period. 11. History of another primary malignancy within 5 years prior to signing the ICF, except for: 1. Adequately treated and cured carcinoma in situ of the cervix; 2. Localized basal cell carcinoma or squamous cell carcinoma of the skin. 12. Receipt of a live attenuated vaccine within 4 weeks prior to signing the ICF, or planned vaccination with a live attenuated vaccine during the screening period. 13. Any condition or complication that, in the investigator's opinion, may affect protocol compliance or make the subject unsuitable for participation in the study. 14. Pregnant or breastfeeding women.
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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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Peking University People's Hospital
RECRUITINGBeijing, Beijing Municipality, 100044, China