Clinical Study of XP-006 mRNA Vaccine for R/R B-NHL
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
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;
Trial design
Treatments tested in this trial
- Personalized neoantigen tumor vaccine
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Ruijin Hospital
Lead sponsor
Shanghai Xinpu BioTechnology Company Limited
Collaborator
Source ClinicalTrials.gov