Cord blood cells take on lymphoma: new hope for relapsed patients
NCT ID NCT06707259
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new therapy made from cord blood immune cells (CAR NK cells) designed to target and kill B-cell lymphoma cells. It is for patients whose cancer has not responded to or has returned after standard treatments. The study will check safety and how well the cells work in 24 adults aged 18-75.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cord blood-derived CAR NK cells (anti-CD19 with IL-10/IL-15)
- What this could lead to
- If successful, this could offer a new treatment option for patients with hard-to-treat B-cell lymphoma who have not responded to standard therapies.
- What could go wrong
- This is an early Phase 1 trial with only 24 participants, so safety and effectiveness are not yet proven. There may be side effects like cytokine release syndrome or the therapy may not work for everyone.
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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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- 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: 1. Volunteer to participate in this study and sign an informed consent form; 2. Age 18-75 years old, no gender limit; 3. Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type:(1) Refractory or relapsed DLBCL refers to the failure to achieve complete remission after 2-line treatment; disease progression during any treatment, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation ; (2) Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors; (3) Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment; (4) Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines; 4. At least one measurable lesion with the longest diameter ≥ 1.5 cm exists; 5. The expected survival period is ≥12 weeks; 6. The puncture section of the tumor tissue was positive for CD19 expression; 7, ECOG score 0-2 points; 7. Sufficient organ function reserve: (1) Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value); (2) Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min; (3) Serum total bilirubin and alkaline phosphatase ≤1.5× UNL; (4)Glomerular filtration rate\>50Ml/min Cardiac ejection fraction (EF) ≥50%; (5) Under natural indoor air environment, basic oxygen saturation\>92% . 8. Allow a previous stem cell transplantation. 9. The approved anti-B-cell lymphoma treatments, such as systemic chemotherapy, systemic radiotherapy, and immunotherapy, have been completed for at least 3 weeks before the study medication; 10. Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation; 11. Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial. 12. Two tests for the new coronavirus were negative. Exclusion Criteria: 1. Those who have a history of allergies to any of the ingredients in cell products; 2. History of other tumors; 3. Previously presented with II-IV degree (Glucksberg criteria) acute GvHD or extensive chronic GvHD; or are receiving anti-GvHD treatment; 4. Have received gene therapy in the past 3 months; 5. Active infections that require treatment (except for simple urinary tract infections and bacterial pharyngitis), but preventive antibiotics, antiviral and antifungal infection treatments are allowed; 6. Hepatitis B (HBsAg positive, but HBV-DNA \<103 is not an exclusion criterion) or hepatitis C virus infection (including virus carriers), syphilis and other subjects with acquired and congenital immunodeficiency diseases, including but not limited to people living with HIV; 7. According to the New York Heart Association's Heart Function Classification Standard, it is classified as Grade III or Grade IV impaired subjects; 8. Those who have received anti-tumor therapy in the early stage but the toxic reaction has not recovered (the CTCAE 5.0 toxic reaction has not recovered to ≤1, except for fatigue, anorexia, and hair loss); 9. Subjects with a history of epilepsy or other central nervous system diseases; 10. Enhanced CT or MRI of the head showed evidence of central nervous system lymphoma; 11\. Have any other drugs that target CD19; 12. Women who are breastfeeding and unwilling to stop breastfeeding; 13. Any other situation that the investigator believes may increase the subject's risk or interfere with the test results.
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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, College of Medicine, Zhejiang University
RECRUITINGHangzhou, Zhejiang, 310009, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Two-Drug combo targets tough Non-Hodgkin's lymphoma
- Triple drug combo targets mantle cell lymphoma
- New drug BL-M08D1 joins standard therapy in fight against aggressive lymphoma
- Can AI spot the lymphoma patients who Won't respond?
- Outpatient immunotherapy tested for hard-to-treat lymphomas