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HIV Associated LymphomaEarly Phase 1NCT07563023

Exploratory Study on the Treatment of EB Virus Positive HIV Associated Lymphoma With EBV mRNA Vaccine

A Early Phase 1 study testing EBV mRNA vaccine in people with HIV Associated Lymphoma, run by West China Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

HIV related lymphoma is characterized by high pathological malignancy, late disease course, poor bone marrow reserves, immune deficiency, and high risk of infection. It is still one of the main causes of death in AIDS patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Associated Lymphoma
What is being tested?
EBV mRNA vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
No sites listed yet
Study dates
1 May 2026to 31 Dec 2028
Phase
Early 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

  • 1. Male or female patients aged ≥ 18 years during screening.
  • 2. Histological or cytological diagnosis of HIV associated lymphoma, including but not limited to diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Hodgkin lymphoma (HL), etc.:
  • Initial treatment population: patients who have not received systematic anti-tumor treatment;
  • Relapse resistant population: patients who have received at least first-line treatment in the past and have experienced treatment failure or intolerance; Relapse is defined as the appearance of new lesions at the primary site or other locations after achieving complete remission (CR); Difficult to treat is defined as any of the following situations: (1) failure to achieve PR after ≥ 2 treatment cycles; (2) failure to achieve CR after ≥ 4 treatment cycles; (3) failure to achieve complete remission after autologous hematopoietic stem cell transplantation; (4) If the best therapeutic effect or end cause is PD, the number of cycles is not required (the same definition applies to relapsed/refractory lymphoma in the following text).
  • 3. Positive for EB virus infection (tissue EBER ISH/FISH testing).
  • 4. Complete at least 2 cycles of systemic chemotherapy without achieving CR (the initial treatment population must complete the entire chemotherapy course of the first-line treatment plan, unless intolerant).
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  • 5. ECOG physical condition score: 0-2 points.
  • 6. Expected survival period ≥ 3 months.
  • 7. The main organ functions well, and the relevant examination indicators meet the following requirements:
  • 8. The subject has no pregnancy plan during the treatment period and agrees to voluntarily take effective contraceptive measures during the trial period and within 4 months of stopping treatment, and the pregnancy of women of childbearing age is negative.
  • 9. Able to understand and voluntarily sign a written informed consent form before the experiment.
  • 10. Able to communicate well with researchers and willing to follow the protocol to complete the experiment.

Who cannot join

  • 1. The patient has a history of other tumors, except for the cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, gastrointestinal intramucosal carcinoma and other malignant tumors that the researchers think can be included.
  • 2. Known to have aggressive NK cell leukemia or concomitant hemophagocytic syndrome.
  • 3. Known to have uncontrolled cardiac clinical symptoms or diseases, such as New York Heart Association (NYHA) grade II or above heart failure, unstable angina, myocardial infarction within 6 months, clinically significant and requiring treatment or intervention in patients with supraventricular or ventricular arrhythmias.
  • 4. Any active autoimmune disease or autoimmune disease history, including but not limited to immune related neurological disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain Barre syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease, including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN) or Stevens Johnson syndrome (except for type I diabetes mellitus using a stable dose of insulin).
  • 5. If there are any uncontrollable clinical diseases (such as respiratory, circulatory, digestive, nervous, hematological, urogenital, endocrine system diseases) or mental illnesses (such as depression, schizophrenia) or other major diseases that, according to the researcher's assessment, may hinder the provision of informed consent, interfere with the interpretation of the trial results, pose risks to the subjects participating in this trial, or otherwise affect the achievement of the trial objectives.
  • 6. Patients with a known history of interstitial pneumonia or highly suspected of having interstitial pneumonia; Patients with lung abnormalities that may interfere with the detection or management of suspected drug-related pulmonary toxicity during the trial period.
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  • 7. Allergic to the experimental drug (including any excipients). Previous history of severe allergies to any medication, food, or vaccine, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.
  • 8. Patients who have had less than 4 weeks or 5 half lives (whichever is shorter) since their last anti-tumor treatment, or whose anti-tumor treatment-related adverse reactions (excluding hair loss) have not recovered to NCI CTCAE ≤ 1 or baseline standards after previous anti-tumor treatments.
  • 9. Subjects who receive systemic therapy with corticosteroids (>10 mg/day of prednisone or equivalent doses of other corticosteroids) or other immunosuppressive agents within 14 days or 5 half lives (whichever is shorter) prior to the first administration. In the absence of active autoimmune diseases, inhalation or topical use of steroids and adrenal hormone replacement with a dose ≤ 10 mg/day of prednisone therapeutic dose is allowed.
  • 10. Within 3 months prior to the first administration, have received mRNA vaccines or similar nanoparticles such as LNP for drug delivery.
  • 11. Previously received organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • 12. Blood donation or significant blood loss (>450 mL) within the first 3 months of screening.
  • 13. Those who have undergone major surgery within the 4 weeks prior to screening (excluding minor surgeries such as catheter placement or biopsy surgery as required by the protocol), or whose impact of surgery or trauma has been eliminated for less than 14 days prior to enrollment.
  • 14. Have a history of drug abuse or known medical, psychological, or social conditions, such as a history of alcohol or drug abuse.
  • 15. Known hepatitis B B virus, hepatitis C virus, and syphilis infection, or hepatitis B B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCVAb), and treponema pallidum (TP) antibody were positive when screening: HBsAg (+) or HBcAb (+), and HBV DNA copy number ≥ 2000 IU/mL (or the lower limit of positive detection value in the research center); HCVAb positive and HCV RNA ≥ ULN of the research center.
  • 16. The patient has a history of active pulmonary tuberculosis (TB) or active TB; Or severe acute or chronic infections that require systemic treatment.
  • 17. Pregnant or lactating women.
  • 18. The researchers believe that there are any other factors that are not suitable for the subjects to enter this trial.

About this study

HIV related lymphoma is characterized by high pathological malignancy, late disease course, poor bone marrow reserves, immune deficiency, and high risk of infection. It is still one of the main causes of death in AIDS patients. EB virus is believed to be involved in the pathogenesis of approximately half of HIV related NHL and almost all HIV related HL; EBV can be found in almost all patients with primary HIV associated central nervous cell lymphoma (PCNSL). With the widespread application of antiretroviral (ART), the incidence rate of NHL has decreased by about 50% due to the reduction of PCNSL and DLBCL immunoblastic subtypes. However, the burden of HIV related BL and HL has increased.

The immune efficacy targeting EBV may provide a new treatment option for EBV positive HIV associated lymphoma. The EBV mRNA vaccine in this study has shown potential anti-tumor efficacy in lymphoma. Considering the close relationship between EBV and the occurrence and development of HIV associated lymphoma, and the lack of standard first-line and second-line treatment options for this population, we plan to continue exploring the application of this product in more types of lymphoma based on previous research.

Being tested
EBV mRNA vaccine
Medical subject headings
Lymphoma, Primary Effusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EBV mRNA vaccineBiological

    EBV mRNA vaccine

Study groups in NCT07563023
Study groupRoleWhat they receive
EBV mRNA vaccine, DL 1ExperimentalNot described
Receives: Biological: EBV mRNA vaccine
EBV mRNA vaccine, DL 2ExperimentalNot described
Receives: Biological: EBV mRNA vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Dose limiting toxicity (DLT) and its incidence rate

    Measured: Within 14 days after the first administration

  2. Safety: Extended Recommended Dose (RDE)

    Measured: Through study completion, an average of 2 years

Secondary outcomes (6)

  1. Objective response rate (ORR)

    Measured: Through study completion, an average of 2 years

  2. Disease control rate (DCR)

    Measured: Through study completion, an average of 2 years

  3. Duration of Relief (DoR)

    Measured: From the date of the first PR/CR to the date of the first confirmation of progress or death for any reason, whichever came first, assessed up to 2 years

  4. progression free survival (PFS)

    Measured: From the date of initial treatment until the first confirmation of progression or death for any reason, whichever came first, assessed up to 2 years

  5. overall survival (OS)

    Measured: From the date of initial treatment until the death for any reason, assessed up to 2 years

  6. Immunogenicity: antigen-specific T cell expression levels

    Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07563023
Sponsor's protocol ID
HIV-EBV-mRNA
Status last verified
Apr 2026
First submitted
20 Apr 2026
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing EBV mRNA vaccine in people with HIV Associated Lymphoma, run by West China Hospital.

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 12 inclusion and 18 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Dose limiting toxicity (DLT) and its incidence rate (time frame: Within 14 days after the first administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07563023.

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 1 May 2026.

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