Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma

A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma

Title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma

Protocol Number: SP071744 Study Stage: Phase I Study Number: 1 site Subject Number: up to 54 patients with Relapsed or Refractory B-cell Lymphoma

Inclusion Criteria:

• 18-75 years, all genders
• Patients with definite B-cell Lymphoma, includes FL, MZL, MCL, DLBCL.
• Patients With Relapsed or Refractory B-cell Lymphoma
• ECOG ≤ 2
• Lesions are measurable in 21 days before treatment
• Normal bone marrow function
• Normal liver, kidney, lung and heart function
• the Subjects can sign the ICF and obey the protocol, elsewise, his/her guardian should sign
• Life expectancy is at least 3 months

Exclusion Criteria:• Past or present CNS disease

• Associated with lymphoma by the infiltrates of CNS
• A history of autoimmune disease with CNS involvement or autoimmune disease
• Previous history of autoimmune disease or other malignancy
• A history of deep venous thrombosis or pulmonary embolism
• Auto-HSCT was performed within 12 weeks prior to initiation of treatment
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation
• The Investigator determined that the patients were associated with a disease, medical condition, or social factor that might affect study results or compliance
• Immunosuppressant are being used
• Radiotherapy was given within 6 weeks prior to A-319 treatment
• Chemotherapy, immunotherapy and targeted therapy were received within 4 weeks before A-319 treatment
• Previous CAR-T cell therapy
• Received anti-lymphoma drugs in the first 4 weeks of A-319 treatment
• There was no recovery of toxic effects (CTCAE> grade 1 adverse events) at the last treatment, except hair loss
• Those who underwent major surgery 28 days before enrollment (excluding lymph node biopsy);Or plan to operate during the study period
• Those who had received active/attenuated live vaccine within 28 days prior to screening
• For pregnant (positive pregnancy test) and lactating women, those of childbearing age who signed the informed consent form and did not agree to use contraception for at least 3 months after the end of the study;Within 7 days prior to the first day of treatment, women of childbearing age require a positive serum pregnancy test (HCG)
• Male patients who signed informed consent forms and did not agree to use contraception for at least 3 months at the end of the study (except surgical sterilization)
• Known allergy to immunoglobulin or research drugs and their excipients
• Patients considered unfit to participate in the study