Overview

This study is a prospective single-arm open-label phase I/II 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.

Eligibility

Inclusion Criteria:

• 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. The results of laboratory tests during the screening period indicate that the subject has appropriate organ function.
• 8. Women and men of childbearing potential should be willing to use highly effective and reliable contraceptive methods for 1 year after receiving the study treatment, and are absolutely prohibited from donating eggs within 1 year after receiving the study treatment infusion during the study period.

Exclusion Criteria:

• 1. Participants with a history of central nervous system (CNS) leukemia/lymphoma, or those with CNS leukemia/lymphoma shown by magnetic resonance imaging (MRI) or positron emission tomography-computed tomography (PET-CT) intracranial imaging during the screening period, or those with detected malignant cells in cerebrospinal fluid or brain metastases.
• 2. History of testicular leukemia/lymphoma, and imaging examinations during the screening period suggest active testicular leukemia/lymphoma.
• 3. If the participant has a history of hematopoietic stem cell transplantation, it should be at least 6 months since the participant received allogeneic hematopoietic stem cell transplantation.
• 4. History of CD19 CAR-T/NK therapy (except for participants who have received GT719 and are eligible for retreatment);
• 5. Received systemic glucocorticoid drugs within 7 days before cell infusion, except inhaled glucocorticoids.
• 6. History of allergic reactions to any components of the drugs intended for use in the study (including but not limited to the study drug GT719 cell infusion preparation, cyclophosphamide, and fludarabine).
• 7. Participants with lymphoma involvement of the cardiac atria or ventricles.
• 8. Active hepatitis B and/or active hepatitis C (HCV RNA positive); participants with positive hepatitis B surface antigen and/or core antibody but with HBV-DNA levels within the normal range may be included.
• 9.Primary immunodeficiency.
• 10. Male and female participants who are unwilling to use contraception from the time of informed consent until 6 months after the completion of treatment.