Pharmacokinetics, Efficacy and Safety of the 304 Injection

June 6, 2019 updated by: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

A Study of Pharmacokinetics, Efficacy, and Safety of 304 Injection Compared With Rituximab in B Cell Non-Hodgkin's Lymphoma

The purpose of this study is to evaluate the pharmacokinetic of the experimental drug 304 injection compared with rituximab injection in patients with CD20 positive B-cell non-Hodgkin lymphoma who had previously achieved CR/CRu status but had not deteriorated or relapsed. While to assess the safety and efficacy of the experimental drug 304 injection compared with rituximab injection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multi-center, randomized, double-blind, parallel controlled, single-dose study to evaluate the pharmacokinetic, safety and efficacy of 304 injection compared with rituximab injection. To avoid the impact of tumor burden on pharmacokinetics, this study will be conducted in CD20 positive B-cell non-Hodgkin lymphoma patients who have achieved CR/CRu status and have not yet deteriorated or relapsed. All patients will be randomly averagely entered into the experimental group and the control group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Recruiting
        • the 307 Hospital of People's Liberation Army
        • Contact:
      • Beijing, Beijing, China, 101100
        • Recruiting
        • Beijing Luhe Hospital Capital Medical University
        • Contact:
        • Principal Investigator:
          • dong Yan
    • Guangdong
      • Guangzhou, Guangdong, China, 510600
        • Recruiting
        • Sun Yat-sen University Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Huiqiang Huang
    • Hebei
      • Shijiazhuang, Hebei, China, 050010
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
    • Heibei
      • Baoding, Heibei, China, 071000
        • Recruiting
        • Affiliated Hospital of Hebei University
        • Contact:
        • Principal Investigator:
          • Aimin Zang
    • Henan
      • Zhengzhou, Henan, China, 450007
        • Recruiting
        • Zhengzhou Central Hospital
        • Contact:
        • Principal Investigator:
          • shanyong Yi
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospita of Zhengzhou University
        • Principal Investigator:
          • Mingzhi Zhang
    • Shandong
      • Weihai, Shandong, China, 264200
        • Recruiting
        • Weihai Municipal Hospital
        • Contact:
    • Tianjing
      • Tianjing, Tianjing, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute &Hospital
        • Contact:
        • Principal Investigator:
          • Lanfang Li
    • Zhejiang
      • Suzhou, Zhejiang, China, 215000
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • Contact:
        • Principal Investigator:
          • Zhixiang Zhuang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological examination confirmed CD20-positive B-cell non-Hodgkin's lymphoma patients (according to WHO 2008 lymphoid tissue tumor type, and a corresponding medical history basis);
  • Previous treatments with CR/CRu (see Appendix 1 for lymphoma efficacy criteria) and those with CD20-positive B-cell non-Hodgkin's lymphoma who have not yet worsened and relapsed believe that they can benefit from anti-CD20 monoclonal antibody therapy. The diagnosis of CRu requires complete raw data (using CT findings. The preferred enhanced CT examination)
  • At the time of enrollment, the Eastern Oncology Cooperative Group (ECOG) had a physical status score of ≤1 (see Appendix 2 for the evaluation criteria for the ECOG physical status score) and the expected survival period was more than four months
  • In the screening test, WBC≥3×109/L, HGB≥80g/L, ANC≥1.5×109/L, PLT≥75×109/L, left ventricular ejection fraction (LVEF) ) ≥ 50%
  • Female patients of childbearing age were negative for the blood pregnancy test during the screening period. Patients of childbearing age are willing to contraception after signing the informed consent form until 6 months after the end of the study treatment, including but not limited to: hormonal contraception, or physical contraception, or abstinence
  • Be able to understand and comply with clinical trial protocol requirements and voluntarily sign written informed consent

Exclusion Criteria:

  • In the past 5 years, there have been other medical history of malignant tumors (except for local malignant tumors that have been cured, such as cutaneous basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or breast carcinoma in situ)
  • Those who have used chemotherapy drugs within 4 weeks before enrollment
  • The clinical half-life of more than 5 drugs after taking other clinical trials in three months or other clinical trials (whichever is longer)
  • The last time you used rituximab or other anti-CD20 mAbs for no more than 4 months
  • In the screening test, the liver and kidney function tests have any of the following abnormalities: total bilirubin > 1.5 times the upper limit of normal, ALT > 2.5 times the upper limit of normal, AST > 2.5 times the upper limit of normal, ALP > 2.5 times the upper limit of normal, Blood Cr>1.5 times the upper limit of normal value
  • Hyperthyroidism
  • He was transfused within 2 weeks before enrollment, or hematopoietic cytokine therapy, such as granulocyte colony-stimulating factor (G-CSF), thrombopoietin, erythropoietin, etc.
  • Those who were vaccinated or planned to vaccinate (attenuate) live virus vaccine within 4 weeks prior to enrollment;
  • Oversized surgery (not including diagnostic surgery) in the past 8 weeks;
  • Have evidence or history of central nervous system involvement or cranial neuropathy;
  • Treponema pallidum antibody positive, or HIV antibody positive, or HCV antibody positive;
  • HBV examination showed one of the following results: a, HBsAg positive; b, although HBsAg negative, but anti-HBc positive and peripheral blood HBV DNA titer can be measured;
  • Have had herpes zoster and have sequelae or latent infections;
  • Patients with a history of severe heart disease, including but not limited to: New York Heart Association NYHA class II-IV heart failure (see Appendix 3 for NYHA heart failure grading), uncontrolled angina or arrhythmia, heart conduction above II Blocking, myocardial infarction occurred within 6 months
  • Serious illnesses that have been or are currently suffering from any other organ or system (including but not limited to: severely active infections, uncontrolled diabetes, uncontrolled hypertension/hypotension, cerebrovascular disease, gastric ulcers, respiratory diseases, activities) Sexual autoimmune diseases, etc.; and any other medical history that the subject judges to be unsuitable for participating in the trial;
  • Pregnant or lactating female subjects, or those who are unwilling to contraception during the trial
  • Severe allergies, or any component known to be rituximab or other anti-CD20 mAbs or allergic to murine proteins;
  • Subjects had a history of drug abuse or a history of smoking and drinking during the first 6 months of enrollment;
  • The investigator judged that the patient was not suitable for entering any other circumstances of the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
304 injection.WILL be administered single dose IV in the patients with CD20 positive B cell NHL
Drug: 304 injection
Monoclonal antibodies, 100mg/10ml per injection
Active Comparator: control group
Rituximab will be administered single dose IV in the patients with CD20 positive B cell NHL.
Drug: rituximab injection
100mg/10ml per injection ，manufactured by Roche

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUC [0-t]
Time Frame: For 85 days
To assess PK parameter of plasma 304 or rituximab: Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUC [0-t])
For 85 days
AUC [0-∞]
Time Frame: For 85 days

To assess PK parameter of plasma 304 or rituximab:

Area under the concentration-time curve from time zero extrapolated to infinity (AUC [0-∞])
For 85 days
Cmax
Time Frame: For 85 days
To assess PK parameter of plasma 304 or rituximab：Observed maximum plasma concentration (Cmax)
For 85 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
tmax
Time Frame: For 85 days
To assess PK parameter of plasma 304 or rituximab：Time to Cmax (tmax)
For 85 days
t1/2
Time Frame: For 85 days
To assess PK parameter of plasma 304 or rituximab：Elimination half-life (t1/2)
For 85 days
MRT
Time Frame: For 85 days
To assess PK parameter of plasma 304 or rituximab：Mean residence time (MRT)
For 85 days
Vz
Time Frame: For 85 days
To assess PK parameter of plasma 304 or rituximab：Apparent volume of distribution(Vz)
For 85 days
CLz
Time Frame: For 85 days
To assess PK parameter of plasma 304 or rituximab：apparent clearance (CLz)
For 85 days
ADA
Time Frame: Up to 9 months
To evaluate the incidence of anti-304 and anti-rituximab antibodies
Up to 9 months
Adverse events
Time Frame: Up to 85 days
To evaluate the adverse events (incidence, severity, outcome, causality with the investigational drug, etc.).
Up to 85 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SSGJ-304-NHL-I-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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