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

January 10, 2026 updated by: Zhao Weili, Ruijin Hospital

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200020
        • Ruijin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoantigen tumor vaccine monotherapy arm
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
Neoantigen tumor vaccine
Other Names:
  • XP-006

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicity (DLT) & Maximum tolerated dose (MTD)
Time Frame: Day1 to Day 21
Day1 to Day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective remission rate at the end of treatment
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Progression-Free Survival (PFS)
Time Frame: Up to approximately 2 years
Progression-free Survival of Personalized mRNA Tumor Vaccine
Up to approximately 2 years
Overall Survival (OS)
Time Frame: Up to approximately 2 years
Overall Survival of Personalized mRNA Tumor Vaccine
Up to approximately 2 years
Reaction of antigen-specific T cells in peripheral blood
Time Frame: Up to 104 weeks
personalized tumor vaccine induced neoantigen-specific CD4+ and CD8+ T lymphocyte responses
Up to 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Shanghai Xinpu BioTechnology Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

January 3, 2026

First Submitted That Met QC Criteria

January 3, 2026

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025PCV006-XP006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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