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.
1. Male or female patients aged ≥ 18 years during screening.
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).
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).
Sequential
EBV mRNA vaccine
Biological/VaccineEBV mRNA vaccine
Safety: Dose limiting toxicity (DLT) and its incidence rate
Safety: Extended Recommended Dose (RDE)
Objective response rate (ORR)
Disease control rate (DCR)
Duration of Relief (DoR)
progression free survival (PFS)
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This trial is not recruiting at the moment. You can still explore other options:
