B-cell Non-Hodgkin's Lymphoma (B-NHL)Phase 1XP-006NCT07334574
Clinical Study of XP-006 mRNA Vaccine for R/R B-NHL
A Phase 1 study testing Personalized neoantigen tumor vaccine in people with B-cell Non-Hodgkin's Lymphoma (B-NHL), run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Non-Hodgkin's Lymphoma (B-NHL)
- What is being tested?
- Personalized neoantigen tumor vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 1 Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital
Shanghai, 200020
Weili Zhao, 64370045, zwl_trial@163.com
About this study
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
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)
- Being tested
- Personalized neoantigen tumor vaccine
- Keywords
- B-cell non-Hodgkin's lymphoma, XP-006, Personalized, Neoantigen
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized neoantigen tumor vaccineBiological
Also called XP-006
Neoantigen tumor vaccine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Personalized neoantigen tumor vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) & Maximum tolerated dose (MTD)
Measured: Day1 to Day 21
Secondary outcomes (4)
Objective remission rate at the end of treatment
Measured: Up to approximately 2 years
Progression-Free Survival (PFS)
Progression-free Survival of Personalized mRNA Tumor Vaccine
Measured: Up to approximately 2 years
Overall Survival (OS)
Overall Survival of Personalized mRNA Tumor Vaccine
Measured: Up to approximately 2 years
Reaction of antigen-specific T cells in peripheral blood
personalized tumor vaccine induced neoantigen-specific CD4+ and CD8+ T lymphocyte responses
Measured: Up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non-Hodgkin's Lymphoma (B-NHL)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Xinpu Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334574
- Sponsor's protocol ID
- 2025PCV006-XP006
- Acronym
- XP-006
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07334574
- Acronym / sponsor ID
- XP-006 / 2025PCV006-XP006
- Conditions
- B-cell Non-Hodgkin's Lymphoma (B-NHL)
- Keywords
- B-cell non-Hodgkin's lymphoma, XP-006, Personalized, Neoantigen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Xinpu Biotechnology Co., Ltd.
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoantigen tumor vaccine monotherapy arm | Experimental | Biological: Personalized neoantigen tumor vaccineDose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized neoantigen tumor vaccineAlso: XP-006Neoantigen tumor vaccine | Biological | Neoantigen tumor vaccine monotherapy arm |
Primary outcome
Dose-limiting toxicity (DLT) & Maximum tolerated dose (MTD)
Time frame: Day1 to Day 21
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Personalized neoantigen tumor vaccine in people with B-cell Non-Hodgkin's Lymphoma (B-NHL), run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao (64370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) & Maximum tolerated dose (MTD) (time frame: Day1 to Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.