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

NCT07334574 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 2025PCV006-XP006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

B-cell Non-Hodgkin's Lymphoma (B-NHL)

Keywords

B-cell non-Hodgkin's lymphoma; XP-006; Personalized; Neoantigen

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT) & Maximum tolerated dose (MTD)

  Day1 to Day 21

Secondary Outcomes (4)

• Objective remission rate at the end of treatment

  Up to approximately 2 years

• Progression-Free Survival (PFS)

  Up to approximately 2 years

• Overall Survival (OS)

  Up to approximately 2 years

• Reaction of antigen-specific T cells in peripheral blood

  Up to 104 weeks

Study Arms (1)

Neoantigen tumor vaccine monotherapy arm

EXPERIMENTAL

Dose Escalation and Randomization Phase vaccine: 0.2mg, 0.4mg, 1 mg. Dose Expansion Phase vaccine: MTD or 1mg. 3 weeks as a treatment cycle, a total of 9 cycles.

Biological: Personalized neoantigen tumor vaccine

Interventions

Personalized neoantigen tumor vaccine BIOLOGICAL

Neoantigen tumor vaccine

Also known as: XP-006

Neoantigen tumor vaccine monotherapy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shanghai Xinpu BioTechnology Company Limited: collaborator

Study Sites (1)

Ruijin Hospital

Shanghai, 200020, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Weili Zhao

CONTACT

64370045; zwl_trial@163.com

Pengpeng Xu

CONTACT

64370045; pengpeng_xu@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 12, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)