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

NCT ID: NCT04056975

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-15
• Study Completion Date: 2022-01-27

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

Conditions

Relapsed or Refractory B-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

A-319 dosage: 0.05, 0.15, 0.03, 0.06, 0.12, 0.18, 0.24 μg/kg

Group Type: EXPERIMENTAL

Recombinant Anti-CD19m-CD3 Antibody Injection

Intervention Type: BIOLOGICAL

Intravenous Infusion

Interventions

Recombinant Anti-CD19m-CD3 Antibody Injection

Intravenous Infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

EVIVE Biotechnology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Song Yuqin, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Central Contacts

Yang Jing, Bachelor

Role: CONTACT

yangj@generonbiomed.com

8613524953174

Other Identifiers

SP071744

Identifier Type: -

Identifier Source: org_study_id