EB virus-positive HIV-associated lymphoma
Conditions
Interventions
Experimental group:WGc-043 Injection
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 years or older at screening. 2. Histologically or cytologically confirmed HIV-related lymphoma, including but not limited to: diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Hodgkin lymphoma (HL), etc.: (1) Treatment-naïve population: patients who have not received systemic antitumor therapy; (2) Relapsed/refractory population: patients who have previously received at least one line of treatment and experienced treatment failure or intolerance; relapse is defined as: occurrence of new lesions in the original or other sites after achieving CR; refractory is defined as any of the following: 1) No PR after >=2 treatment cycles; 2) No CR after >=4 treatment cycles; 3) No complete remission after autologous hematopoietic stem cell transplantation; 4) If the best response or reason for discontinuation is PD, the number of cycles is not required (the same definition applies below for relapsed/refractory lymphoma). 3. Positive for Epstein-Barr virus infection (tissue EBER ISH/FISH testing). 4. Completed at least 2 cycles of systemic chemotherapy and have not achieved CR (treatment-naïve patients must complete the full course of first-line chemotherapy unless intolerant). 5. Eastern Cooperative Oncology Group (ECOG) performance status score: 0–2. 6. Expected survival >=3 months. 7. Major organ function is adequate, and relevant test indicators meet the following requirements: (1) Hemoglobin >=80 g/L, neutrophil count >=1.0 x 10^9/L, platelet count >=75 x 10^9/L; for those with bone marrow infiltration: hemoglobin >=70 g/L, neutrophil count >=0.5 x 10^9/L, platelet count >=50 x 10^9/L; (2) Total bilirubin =45 mL/min (Cockcroft-Gault formula); (4) Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >=45%; (5) If the investigator believes that any of the above test indicators are below the protocol limit due to lymphoma progression, enrollment can be decided after medical discussion with the sponsor and CRO. 8. Subjects have no plans for pregnancy during treatment and agree to voluntarily use effective contraception during the trial and for 4 months after stopping treatment, and women of childbearing potential must test negative for pregnancy. 9. Able to understand and voluntarily sign a written informed consent form before the trial. 10. Able to communicate well with the investigator and willing to comply with the protocol to complete the trial.
Exclusion criteria
Exclusion criteria: 1. Patients have a history of other tumors, but except for the history of malignant tumors that have been cured and have not recurred within 5 years before screening, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer in situ, and intramucosal cancer of the gastrointestinal tract, which the investigator thinks can be enrolled. 2. Known invasive NK cell leukemia or with hemophagocytic syndrome. 3. Patients with known cardiac clinical symptoms or diseases that are not well controlled, such as: New York Heart Association (NYHA) Class II or above heart failure, unstable angina, myocardial infarction within 6 months, patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. 4. Any active autoimmune disease or history of autoimmune disease, including but not limited to immune-related neurological disorders, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disorders, scleroderma, inflammatory bowel diseases including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson Syndrome (except type I diabetes mellitus on a stable dose of insulin). 5. Have any uncontrollable clinical disease (e.g., respiratory, circulatory, digestive, neurological, hematological, genitourinary, endocrine system) or psychiatric disease (e.g., depression, schizophrenia) or other major illness as assessed by the investigator that will prevent the provision of informed consent, interfere with the interpretation of the trial results, may pose risks to the subject by participating in this trial, or otherwise affect the achievement of the purpose of the trial. 6. Patients with a known history of interstitial pneumonia or high suspicion of interstitial pneumonia; or patients with pulmonary abnormalities that may interfere with the detection or management of suspected drug-related pulmonary toxicity during the trial. 7. Allergy to the trial drug (including any excipients). Previous history of severe allergies to drugs, foods, and vaccinations, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc. 8. Patients whose most recent anti-tumor therapy is less than 4 weeks or 5 half-lives (whichever is shorter) from the first vaccination, or who have not recovered to NCI CTCAE grade 10 mg/day of prednisone or equivalent doses of other glucocorticoids) or other immunosuppressive agents within 14 days or 5 half-lives (whichever is shorter) prior to the first dose. Inhaled or topical steroids and adrenal hormone replacement at doses 450 mL) within 3 months prior to screening. 13. Major surgery within 4 weeks prior to screening (minor surgery su
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity (DLT) and its incidence;Adverse reaction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary antitumor activity: Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DoR), Progression-Free Survival (PFS), Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactJiayin Yang
West China Hospital of Sichuan University
Outcome results
None listed