Engineered immune cells take on tough lymphoma
NCT ID NCT07508605
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a new type of cell therapy called CD19/CD20 CAR/TRuC-T for people with B-cell lymphoma that has come back or not responded to standard treatments. The therapy uses a patient's own immune cells, which are modified in a lab to better recognize and attack cancer cells. The trial will enroll 20 adults and primarily check for safety, while also looking at whether the treatment can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD19/CD20 CAR/TRuC-T cells (a type of immune cell therapy)
- What this could lead to
- If it works, this could offer a new treatment option for patients whose lymphoma has not responded to other therapies.
- What could go wrong
- This is a very early (Phase 1/2) and small trial with only 20 participants. The therapy may cause serious side effects, and it is not yet known if it will effectively 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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2027
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 to 75 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 Subjects must meet all of the following criteria to be enrolled: 1. Aged 18 to 75 years, regardless of sex; 2. Histologically confirmed relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) classification; 3. ECOG performance status of 0-2; 4. Expected survival of at least 3 months; 5. CD20 expression on tumor cells confirmed by flow cytometry and/or immunohistochemistry; 6. Patients who are resistant/refractory to CD19 CAR-T cell therapy or have low CD19 expression; 7. No severe cardiac, pulmonary, hepatic, or renal disease; 8. Able to understand and willing to sign the informed consent form for this study; 9. No contraindications to peripheral blood mononuclear cell collection/apheresis; 10. At least one measurable and evaluable lesion according to RECIST 1.1; 11. Must have previously received standard first-line and second-line therapy; 12. No antibody-based therapy within 2 weeks prior to cell therapy. Exclusion Criteria Subjects meeting any of the following criteria will be excluded: 1. History of allergy to any component of the cell product; 2. Abnormal complete blood count meeting any of the following: WBC ≤1 × 10⁹/L, ANC ≤0.5 × 10⁹/L, ALC ≤0.5 × 10⁹/L, or PLT ≤25 × 10⁹/L; 3. Laboratory abnormalities including, but not limited to, any of the following: total serum bilirubin ≥1.5 mg/dL; ALT or AST \>2.5 times the upper limit of normal; serum creatinine ≥2.0 mg/dL; 4. New York Heart Association (NYHA) Class III or IV heart failure, or left ventricular ejection fraction (LVEF) \<50% on echocardiography; 5. Abnormal pulmonary function, with oxygen saturation \<92% on room air; 6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment; 7. Grade 3 hypertension with poor blood pressure control despite medication; 8. History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease; 9. Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy; 10. Presence of uncontrolled active infection; 11. Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy; 12. Receipt of a live vaccine within 4 weeks prior to enrollment; 13. Positive for HIV, HBV, HCV, or TPPA/RPR, or HBV carrier status; 14. History of alcohol abuse, drug abuse, or psychiatric illness; 15. Participation in any other clinical study within 3 months prior to enrollment in this study; 16. Female subjects meeting any of the following conditions: 1. currently pregnant or breastfeeding; 2. planning to become pregnant during the study period; or 3. of childbearing potential and unwilling or unable to use effective contraception; 17. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
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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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Shenzhen University General Hospital
RECRUITINGShenzhen, Guangdong, 518055, China
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