A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in Adult Participants With Relapsed/Refractory CD19-positive B-cell Malignant Hematological Tumors
This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in relapsed/refractory CD19 positive adult B-cell non Hodgkin lymphoma (B-NHL) and B-acute lymphoblastic leukemia (B-ALL) patients. A total of 34 subjects will be enrolled in this study.
• 1\. Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.
• 2\. Aged 18 to 75 years (inclusive), regardless of gender.
• 3\. Participants with refractory or relapsed acute B-cell lymphoblastic leukemia or B-cell lymphoma diagnosed according to the WHO 2016 classification.
• 4\. CD19 positivity confirmed by flow cytometry and/or histopathology.
• 5\. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
• 6\. Expected survival period \> 12 weeks;
• 7\. For any prior systemic therapy (excluding immune checkpoint inhibitors), at least 2 weeks or 5 half-lives (whichever is shorter) must have elapsed before the participant is scheduled to receive the study treatment. For any prior treatment with immune checkpoint inhibitors (such as anti-PD-1 or anti-PD-L1 monoclonal antibodies like Pembrolizumab, OX40 agonists, 4-1BB agonists, etc.), at least 3 half-lives or 28 days (whichever is shorter) must have passed before the participant is scheduled to receive the study treatment.
• 8\. Toxicities caused by prior treatments must be stable and resolved to grade ≤ 1, excluding clinically insignificant toxicities such as alopecia.
• 9\. Have adequate renal, hepatic, pulmonary, and cardiac functions, defined as follows:
‣ . Creatinine Clearance (estimated by the Cockcroft-Gault formula) ≥ 60 mL/min;
⁃ . Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 times the Upper Limit of Normal (ULN);
⁃ . Total bilirubin ≤ 1.5 mg/dl, excluding participants with Gilbert syndrome;
⁃ . Cardiac ejection fraction ≥ 50%, no signs of pericardial effusion detected by Echocardiography (ECHO), and no clinically significant abnormalities found on Electrocardiogram (ECG);
⁃ . No clinically significant pleural effusion;
⁃ . Baseline oxygen saturation \> 92% when measured under room air conditions.
• 10\. Female participants of childbearing potential must have a negative result from a serum or urine pregnancy test. Females who have undergone surgical sterilization or been postmenopausal for at least 2 years are not considered to be of childbearing potential. They must agree to use highly effective and reliable contraceptive methods for 1 year after receiving the study treatment, and are strictly prohibited from donating oocytes within 1 year after the infusion of the study treatment during the study period.
• 11\. Male participants who have active sexual life with females of childbearing potential must agree to use highly effective and reliable contraceptive methods for 1 year after receiving the study treatment. All male participants are strictly prohibited from donating sperm within 1 year after the infusion of the study treatment during the study period.