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Clinical Study of XP-006 mRNA Vaccine for R/R B-NHL | Clinical Trials | Clareo Health

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

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

NCT07334574•Ruijin Hospital

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (1)

Ruijin Hospital

Shanghai, China

Key Dates

Start Date

January 15, 2026

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2029

Last Updated

January 13, 2026

Enrollment

ESTIMATED participants

Conditions

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

Interventions

Personalized neoantigen tumor vaccine

BIOLOGICAL

Contacts

Weili Zhao

CONTACT

64370045 zwl_trial@163.com

Pengpeng Xu

CONTACT

64370045 pengpeng_xu@126.com