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

Last updated: August 13, 2019
Sponsor: Generon (Shanghai) Corporation Ltd.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Lymphoma

Lymphoma, B-cell

Treatment

N/A

Clinical Study ID

NCT04056975
SP071744
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 shouldsign

  • Life expectancy is at least 3 months

Exclusion

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, medicalcondition, 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 beforeA-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 lasttreatment, except hair loss

  • Those who underwent major surgery 28 days before enrollment (excluding lymph nodebiopsy);Or plan to operate during the study period

  • Those who had received active/attenuated live vaccine within 28 days prior toscreening

  • For pregnant (positive pregnancy test) and lactating women, those of childbearing agewho signed the informed consent form and did not agree to use contraception for atleast 3 months after the end of the study;Within 7 days prior to the first day oftreatment, women of childbearing age require a positive serum pregnancy test (HCG)

  • Male patients who signed informed consent forms and did not agree to use contraceptionfor 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

Study Design

Total Participants: 54
Study Start date:
September 15, 2019
Estimated Completion Date:
January 27, 2022

Study 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