Can 'Memory-Enhanced' immune cells outsmart lymphoma?
NCT ID NCT07788118
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This trial is testing an experimental cell therapy called 7×19-THEMIS CAR-T for people with large B-cell lymphoma that has returned or not responded to previous treatments. The therapy involves taking a patient's own immune cells, engineering them to better recognize and attack cancer cells, and giving them back. The study aims to see if this approach can shrink tumors and achieve remission, while also checking its safety and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Memory-enhanced 7×19-THEMIS CAR-T cells (engineered immune cells that target CD19 and produce IL7 and CCL19)
- What this could lead to
- If successful, this could offer a more effective treatment option for patients with large B-cell lymphoma that has returned or not responded to standard therapies, potentially leading to higher remission rates.
- What could go wrong
- This is an early-phase trial, so the therapy may not work as hoped or could cause severe side effects like cytokine release syndrome or neurological toxicity. Results need confirmation in larger studies.
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 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2031
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: 1. Voluntarily participate in this study and sign the informed consent form. 2. Age range: 18 - 75 years old. Gender is not restricted. 3. Histologically confirmed large B-cell lymphoma, including: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (tFL), and mantle cell lymphoma (MCL). 4. CD19-positive (as determined by immunohistochemistry or flow cytometry; based on the most recent tumor biopsy results). 5. Definition of relapsed/refractory: Failure to achieve complete remission (CR) after at least two lines of therapy (which must include a CD20 monoclonal antibody and an anthracycline); or disease progression during any course of treatment; or relapse/progression within 12 months after autologous hematopoietic stem cell transplantation. 6. At least one measurable lesion: any lymph node lesion with a longest dimension \>1.5 cm, or any extranodal lesion with a longest dimension \>1.0 cm, and the lesion shows uptake on PET-CT (SUV greater than the hepatic pool). 7. Absolute neutrophil count in peripheral blood ≥ 1,000/μL; platelet count ≥ 45,000/μL. 8. Cardiac, hepatic, and renal function: creatinine \< 1.5 mg/dL; ALT/AST ≤ 2.5 times the upper limit of normal; total bilirubin \< 1.5 mg/dL; ejection fraction ≥ 50%. 9. Possess sufficient cognitive capacity to voluntarily sign the informed consent form. 10. Participants of reproductive potential must be willing to use effective contraception (from the time of signing the informed consent form until 12 months after CAR-T infusion). 11. The investigator estimates a life expectancy of at least 4 months. 12. Willing to comply with the schedule of visits, dosing regimen, laboratory tests, and other trial procedures. Exclusion Criteria: 1. History of other malignant tumors (excluding cured basal cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, etc.). 2. Autologous hematopoietic stem cell transplantation within the past 6 weeks. 3. Any targeted CAR-T therapy within 3 months prior to this CAR-T treatment. 4. Patients who have previously received PD-1 monoclonal antibodies must have a washout period of ≥3 months before enrollment. 5. Received cytotoxic drugs, glucocorticoids (except for prednisone-equivalent doses of ≤10 mg/day), or other targeted therapies within 2 weeks prior to cell collection. 6. Active autoimmune diseases (e.g., systemic lupus erythematosus, inflammatory bowel disease, etc.). 7. Uncontrolled active bacterial, fungal, or viral infections. 8. HIV infection, syphilis; active hepatitis B or C: Hepatitis B: HBsAg-positive and HBV-DNA ≥ 1,000 IU/mL; Hepatitis C: HCV RNA-positive and abnormal liver function. 9. Known central nervous system lymphoma (confirmed by brain MRI or CT and cerebrospinal fluid examination).
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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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The Second Affiliated Hospital,School of Medicine,Zhejiang University, Hangzhou, Zhejiang 310009
RECRUITINGHangzhou, Zhejiang, 310009, China
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