RGL-305+ Lymphoma + Exploratory Clinical Study

Exclusion Criteria17

• Previous adoptive cell therapy, including but not limited to tumor-infiltrating lymphocytes (TILs), chimeric antigen receptor T cells (CAR-T), and T cell receptor chimeric T cells (TCR-T);
• Have previously received or planned to undergo organ transplantation or allogeneic stem cell or allogeneic bone marrow transplantation;
• Combined with congenital or acquired immunodeficiency such as cellular immunodeficiency (e.g., DiGeorge syndrome, T-negative severe combined immunodeficiency \[SSCID\]) or combined T-cell and B-cell immunodeficiency (e.g., T-and B-negative combined immunodeficiency, Wiskott-Aldrich syndrome, ataxic telangiectasia, often) See variable immune deficiency); Or infected with human immunodeficiency virus (HIV);
• The presence of autoimmune diseases, except for patients with hypothyroidism due to autoimmune thyroiditis who only need hormone replacement therapy;
• History of epilepsy or other central nervous system diseases, or lymphoma invading the central nervous system;
• Complicated with other malignant tumors, except malignant tumors with disease-free survival of more than 3 years and carcinoma in situ;
• History of allergy to blood products, known to be allergic to test substances;
• Any non-hematological toxicity associated with previous treatment does not return to ≤ grade 1, except for hair loss and peripheral neurotoxicity;
• Those who had undergone major surgery (≥ Grade 3 surgery) within 4 weeks before the start of study treatment, or who required elective surgery during the trial period;
• Have an poorly controlled or severe cardiovascular disease, such as symptomatic congestive heart failure (NYHA class III or IV), a myocardial infarction within 6 months prior to study initiation, or unstable angina within 1 month prior to study initiation, or an arrhythmia requiring treatment or intervention, Or hypertension remains poorly controlled after adequate treatment (systolic blood pressure ≥150mmHg, diastolic blood pressure ≥90mmHg);
• Known hereditary or acquired bleeding or thrombotic tendencies;
• Subjects with a known or highly suspected history of interstitial pneumonia, or evidence of active interstitial pneumonia on chest CT during the pre-screening period; Known history of idiopathic pulmonary fibrosis, institutional pneumonia (such as bronchiolitis obliterans or cryptogenic institutional pneumonia); Subjects who may interfere with the detection or management of suspected drug-related pulmonary toxicity;
• A severe infection occurring within 28 days prior to study initiation (such as intravenous antibiotics, antifungal, or antiviral drugs as required by clinical practice), or an active infection receiving therapeutic intravenous or oral antibiotics within 14 days prior to study initiation, or an unexplained fever;
• Active hepatitis B (HBV), hepatitis C (HCV), cytomegalovirus (CMV), EB virus (EBV), HIV, syphilis infection;
• Plan to receive live attenuated vaccine (inactivated vaccine is allowed) within 28 days before the start of study treatment or during the study period and 90 days after the end of study drug treatment;
• In the investigator's judgment, the subject has other factors that may affect the study results or lead to the forced termination of the study treatment;
• During the study period, subjects considering fertility, female subjects became pregnant or breastfed within 6 months of the last study drug administration.