Clinical Study of XP-006 mRNA Vaccine for R/R B-NHL (NCT07334574) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Clinical Study of XP-006 mRNA Vaccine for R/R B-NHL
China20 participantsStarted 2026-01-15
Plain-language summary
The main objective of this study is to observe and evaluate the safety and tolerability of the XP-006 personalized tumor mRNA vaccine for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma. Secondary objectives focus on evaluating preliminary efficacy through several parameters: XP-006-induced antigen-specific CD4+/CD8+ T cell activation levels, objective remission rate (ORR), complete remission rate (CRR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects voluntarily signed written informed consent files, able to comply with the study protocol, in the investigator's judgment.
✓. Subjects must be ≥18 years of age at time of informed consent, regardless of gender.
✓. B-NHL was confirmed by histology according to world Health Organization (WHO) disease classification (excluding primary central lymphoma and HIV-associated lymphoma).
✓. 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.
✓. Gene mutation and the peripheral blood HLA typing both meet the requirements of the vaccine.
✓. There are evaluable lesions detected by PET/CT.
✓. Life expectancy of more than 3 months.
✓. ECOG 0-2 points.
Exclusion criteria
✕. Pregnant or lactating women (lactating women must agree not to breastfeed while taking pomadomide);
✕. 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;
What they're measuring
1
Dose-limiting toxicity (DLT) & Maximum tolerated dose (MTD)
. Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;
✕. 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;
✕. 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%;
✕. Lymphoma with central nervous system (CNS) involvement;
✕. Those who are known to be allergic to the test drug ingredients;
✕. Those who have received grade II or above surgery within three weeks before treatment;