Overview
The goal of this clinical study is to evaluate the safety and efficacy of GT801 injection in adult patients with relapsed/refractory CD19-positive B-cell hematologic malignancies.
Eligibility
Inclusion Criteria:
- Aged 18 to 75 years (inclusive), male or female;
- Participants with refractory or relapsed acute B-cell lymphoblastic leukemia (B-ALL) or B-cell lymphoma diagnosed according to the WHO 2016 classification;
- Disease progression or recurrence after at least second-line drug treatment;
- CD19 positivity confirmed by flow cytometry and/or histopathology;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Expected survival period > 12 weeks
Exclusion Criteria:
- Participants with a history of central nervous system leukemia/lymphoma, or those with central nervous system (CNS) leukemia/lymphoma shown by magnetic resonance imaging (MRI) or PET-CT intracranial imaging during the screening period, or those with detectable malignant cells in cerebrospinal fluid or brain metastases;
- Participants who undergo hematopoietic stem cell transplantation with therapeutic intent within 12 weeks of planned GT801 infusion;
- If the participant has a history of hematopoietic stem cell transplantation, the time since the participant received allogeneic hematopoietic stem cell transplantation is ≤ 6 months;
- Active hepatitis B and/or active hepatitis C (HCV RNA positive); participants who are positive for hepatitis B surface antigen and/or core antibody but have HBV-DNA test results within the normal range can be included;
- Presence of central nervous system diseases or a history thereof, such as epileptic seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases involving the central nervous system;
- Presence of any of the following conditions within 6 months before signing the informed consent form: uncontrolled congestive heart failure (New York Heart Association Class III-IV), angina pectoris, myocardial infarction, cardiomyopathy, stroke (except lacunar infarction), coronary/peripheral artery bypass surgery, arrhythmias with significant clinical significance (as judged by the investigator) including but not limited to ventricular arrhythmias, significantly prolonged QT interval (recommended QTc ≥ 500ms corrected by Bazett's method, specifically judged by the investigator), poorly controlled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg), poorly controlled diabetes, pulmonary embolism, diffuse pulmonary lesions, pulmonary insufficiency, or medical conditions that the investigator deems unsuitable for the participant to participate in this clinical study;
- A history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus) that caused end-organ damage or required systemic immunosuppression/systemic disease-modifying agents within the past 2 years.