Relapsed or Refractory B-cell Lymphoma
Conditions
Brief summary
Title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
Detailed description
Protocol Number: SP071744 Study Stage: Phase I Study Number: 1 site Subject Number: up to 54 patients with Relapsed or Refractory B-cell Lymphoma
Interventions
BIOLOGICALRecombinant Anti-CD19m-CD3 Antibody Injection
Intravenous Infusion
Sponsors
Peking University Cancer Hospital & Institute
EVIVE Biotechnology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the MTD and DLT of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | At the end of Cycle 1 (each cycle is 28 days) | dose limited toxicity(DLT), maximum tolerance dose(MTD) |
| Evaluate the Incidence and Characteristics of SAE of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | At the end of Cycle 1 (each cycle is 28 days) | Incidence and Characteristics of SAE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the PK(Tmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | At the end of Cycle3 (each cycle is 28 days) | time to peak (Tmax) |
| Evaluate the PK(T1/2) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | At the end of Cycle3 (each cycle is 28 days) | half-life time(T1/2) |
| Evaluate the PK(Cmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | At the end of Cycle3 (each cycle is 28 days) | Peak Plasma Concentration(Cmax) |
| Evaluate the PK(Vz) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | At the end of Cycle3 (each cycle is 28 days) | volume of distribution(Vz) |
| Evaluate the PD of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | At the end of Cycle3 (each cycle is 28 days) | B-cell level |
| Evaluate the PK(CL) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | At the end of Cycle3 (each cycle is 28 days) | clearance(CL) |
| Evaluate the PK(AUC) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma | At the end of Cycle3 (each cycle is 28 days) | Area under the plasma concentration versus time curve(AUC) |
Contacts
Primary ContactYang Jing, Bachelor
Outcome results
None listed