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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04056975
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Beijing Cancer Hospital
Information provided by (Responsible Party):
Generon (Shanghai) Corporation Ltd.

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

Condition or disease Intervention/treatment Phase
Relapsed or Refractory B-cell Lymphoma Biological: Recombinant Anti-CD19m-CD3 Antibody Injection Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : January 27, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: single arm
A-319 dosage: 0.05, 0.15, 0.03, 0.06, 0.12, 0.18, 0.24 μg/kg
Biological: Recombinant Anti-CD19m-CD3 Antibody Injection
Intravenous Infusion




Primary Outcome Measures :
  1. Evaluate the Incidence and Characteristics of SAE of A-319 Treat on Relapsed or Refractory B-cell Lymphoma [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Incidence and Characteristics of SAE

  2. Evaluate the MTD and DLT of A-319 Treat on Relapsed or Refractory B-cell Lymphoma [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    dose limited toxicity(DLT), maximum tolerance dose(MTD)


Secondary Outcome Measures :
  1. Evaluate the PK(Cmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma [ Time Frame: At the end of Cycle3 (each cycle is 28 days) ]
    Peak Plasma Concentration(Cmax)

  2. Evaluate the PK(AUC) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma [ Time Frame: At the end of Cycle3 (each cycle is 28 days) ]
    Area under the plasma concentration versus time curve(AUC)

  3. Evaluate the PK(Tmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma [ Time Frame: At the end of Cycle3 (each cycle is 28 days) ]
    time to peak (Tmax)

  4. Evaluate the PK(T1/2) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma [ Time Frame: At the end of Cycle3 (each cycle is 28 days) ]
    half-life time(T1/2)

  5. Evaluate the PK(CL) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma [ Time Frame: At the end of Cycle3 (each cycle is 28 days) ]
    clearance(CL)

  6. Evaluate the PK(Vz) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma [ Time Frame: At the end of Cycle3 (each cycle is 28 days) ]
    volume of distribution(Vz)

  7. Evaluate the PD of A-319 Treat on Relapsed or Refractory B-cell Lymphoma [ Time Frame: At the end of Cycle3 (each cycle is 28 days) ]
    B-cell level



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:• 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056975


Contacts
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Contact: Yang Jing, Bachelor 8613524953174 yangj@generonbiomed.com

Sponsors and Collaborators
Generon (Shanghai) Corporation Ltd.
Beijing Cancer Hospital
Investigators
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Principal Investigator: Song Yuqin, Doctor Beijing Cancer Hospital
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Responsible Party: Generon (Shanghai) Corporation Ltd.
ClinicalTrials.gov Identifier: NCT04056975    
Other Study ID Numbers: SP071744
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD
Supporting Materials: Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After 20January2022(estimated), for 1years(estimated).
Access Criteria: All.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies
Immunologic Factors
Physiological Effects of Drugs