Clinical Study of XP-006 mRNA Vaccine for R/R B-NHL

Official title

A Safety, Tolerability and Efficacy Study of XP-006 Personalized Tumor mRNA Vaccine for Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

Overview

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).

Interventions

• Biological Personalized neoantigen tumor vaccine
  Neoantigen tumor vaccine

Primary outcome measures

• Dose-limiting toxicity (DLT) & Maximum tolerated dose (MTD) [Time frame: Day1 to Day 21]

Secondary outcome measures (4)

• Objective remission rate at the end of treatment [Time frame: Up to approximately 2 years]
• Progression-Free Survival (PFS) [Time frame: Up to approximately 2 years]
• Overall Survival (OS) [Time frame: Up to approximately 2 years]
• Reaction of antigen-specific T cells in peripheral blood [Time frame: Up to 104 weeks]

Eligibility criteria

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.
• 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

• 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;
• 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;
• Patients who have received organ transplants;
• 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.
• With severe infection;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Ruijin Hospital — Shanghai

Identifiers

NCT: NCT07334574 · 2025PCV006-XP006

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗