New mRNA vaccine targets Hard-to-Treat lymphoma
NCT ID NCT07334574
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a personalized mRNA vaccine (XP-006) for people with B-cell non-Hodgkin's lymphoma that has returned or not responded to treatment. The vaccine is custom-made to target each person's tumor. The main goal is to check safety and find the right dose, while also looking at how well it controls the disease. About 20 adults will take part.
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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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
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. Subjects voluntarily signed written informed consent files, able to comply with the study protocol, in the investigator's judgment. 2. Subjects must be ≥18 years of age at time of informed consent, regardless of gender. 3. B-NHL was confirmed by histology according to world Health Organization (WHO) disease classification (excluding primary central lymphoma and HIV-associated lymphoma). 4. Prior treatment with sufficient first-line anti-lymphoma therapy, no remission within 90 days of the last administration, or disease progression after sufficient first-line anti-lymphoma therapy, and no current anti-lymphoma therapy (≥2 weeks since the last anti-lymphoma therapy). Patients were allowed to receive hormone drugs or rituximab at least 1 week after enrollment for symptom control reasons. 5. Gene mutation and the peripheral blood HLA typing both meet the requirements of the vaccine. 6. There are evaluable lesions detected by PET/CT. 7. Life expectancy of more than 3 months. 8. ECOG 0-2 points. 9. No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) : ① Absolute value of neutrophil count ≥1500/mm3; Platelet count ≥75,000/mm3 ② Total bilirubin ≤2× upper limit of normal value (ULN) ③ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (serum glutamate pyruvate aminotransferase \[SGPT\]) ≤3× upper limit of normal value (ULN) ④ the creatinine clearance rate was ≥60ml/min ⑤ No cardiac dysfunction. Exclusion Criteria: 1. Pregnant or lactating women (lactating women must agree not to breastfeed while taking pomadomide); 2. Known hepatitis B (HBV), hepatitis C (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit); And other acquired, congenital immune deficiency disorders, including but not limited to HIV-infected persons; 3. Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months; 4. Bone marrow failure, defined as ANC\<1500/mm3 or platelet \<75,000/mm3, unless hematologic changes are thought to be associated with lymphomas infiltrating the bone marrow; 5. Clinically significant heart disease, including unstable angina, acute myocardial infarction 6 months before enrollment, congestive heart failure (NYHA) heart function grade III or IV; Or left ventricular ejection fraction \<50%; 6. Lymphoma with central nervous system (CNS) involvement; 7. Those who are known to be allergic to the test drug ingredients; 8. Those who have received grade II or above surgery within three weeks before treatment; 9. Patients who have received organ transplants; 10. Has been diagnosed with or is being treated for malignancy other than lymphoma, except for: ① They have received therapeutic treatment and have not had known active disease malignancy for ≥5 years prior to enrollment; ② Basal cell carcinoma of the skin (except melanoma) without signs of disease after adequate treatment; ③ Cervical carcinoma in situ without signs of disease after adequate treatment. 11. With severe infection; 12. Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results; The researchers deemed unsuitable for the group.
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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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Ruijin Hospital
Shanghai, 200020, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.