Malignant hematological tumors
Conditions
Interventions
Experimental group:New oncolytic virus preparation:
1 × 10^7-9 pfu/kg, intravenous injection, once a week until progression.
Sponsors
Foresea Life Insurance Nanning Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form and be willing and able to comply with the visit, treatment plan, laboratory tests, and other requirements of the study as specified in the trial protocol; 2.18 years old = 3 months; 5. Relapsed refractory lymphoma/leukemia diagnosed according to WHO2016 standards and NCCN guidelines; 6. At least one measurable lesion (Lugano 2014 standard) should be used as the evaluation basis. For intranodal lesions, the length and diameter should be >= 1.5cm and >= 1.0cm respectively. For extranodal lesions, the length and diameter should be >= 1.0cm (based on imaging test data from our hospital within 30 days before receiving informed consent during the screening period, and without any other anti-tumor treatment). 7. The functional level of important organs must meet the following criteria: a. Serum creatinine = 50% d. Hemoglobin >= 80g/L; Platelet count >= 75 × 10^9/L; Absolute neutrophil count (ANC) >= 1.0 × 10^9/L; e. Minimum lung function reserve required (respiratory distress not exceeding grade 1 (according to CTCAE5.0 standards) and percutaneous arterial oxygen saturation>91% under indoor conditions); 8. Male patients with reproductive ability or female patients with the possibility of pregnancy must meet one of the following criteria: a. have undergone surgical sterilization; b. Female patients who have been menopausal for >= 2 years or have a negative serum pregnancy test during the screening period; c. Agree to use highly effective contraceptive methods such as oral contraceptives, intrauterine devices, or barrier contraception combined with spermicides within 2 years after screening and cell infusion. 9.Patients and/or legal representatives who understand the situation of this study voluntarily agree to participate in this trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of allergies to medicinal excipients (whether active or not); 2. Have taken other drugs currently undergoing clinical trials within 30 days prior to the first administration; 3. Diagnosed with a second tumor within the past 5 years; 4. Individuals who have suffered significant traumatic injuries within 2 weeks prior to the first use of the investigational drug; Participants in the study may receive other anti-tumor treatments during the research period, which may prevent them from continuing with the study; 5. Participants in the experiment have active gastrointestinal diseases or other conditions that may significantly affect drug absorption, distribution, metabolism, or excretion; 6. Uncontrollable chronic systemic comorbidities (such as severe chronic lung, liver, kidney, or heart disease); 7. According to NYHA standards, patients with grade III-IV heart failure; 8. Patients with baseline ECG QTc prolongation (QTcF: males>450 ms, females>470 ms); 9. Any of the following cardiac criteria: a) Screening period resting electrocardiogram (ECG) showing corrected QT interval (QTc)>470 milliseconds; b) Any clinically significant abnormalities in rhythm, conduction, or morphology displayed by resting ECG results, such as complete left bundle branch block, grade II or higher heart block, PR interval>250 milliseconds, etc; c) Any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in first-degree relatives under the age of 40, and the use of any known concomitant medication that can prolong the QT interval; 10. Any serious issues related to clinical research that cannot be controlled (such as substance abuse, uncontrolled mental illness, uncontrolled complications, including active infections, arterial thrombosis, and symptomatic pulmonary embolism); 11. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of interstitial lung disease during clinical activity; 12. The experimental participants are currently in the acute infection phase and require medication and antiviral treatment; 13. Test participants tested positive for HIV, HBV, and HCV (HBV virus copy number >= 10^4 copies/mL, HCV virus copy number >= 10^3 copies/mL); 14. Based on the judgment of the researchers, objective conditions (including the patient's psychological state, family relationships, social or regional factors, etc.) that prevent the patient from completing the planned study, or other factors that may force the study to be terminated midway, as well as concomitant treatments or abnormal laboratory tests, may affect the participants; 15. According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (such as poorly controlled hypertension, serious diabetes, thyroid disease, etc 16. Pregnant or lactating women; 17. Autoimmune diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Progression-Free-Survival (PFS);Overall Survival Time (OS);Quality of Life (QOL); | — |
Countries
China
Contacts
Public ContactGuosheng Feng
Foresea Life Insurance Nanning Hospital
Outcome results
None listed