Pharmacokinetics, Efficacy and Safety of the 304 Injection

NCT03980379 | Unknown Phase 1

• 1 other identifier: SSGJ-304-NHL-I-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

CD20 Positive B Cell NHL

Outcome Measures

Primary Outcomes (3)

• AUC [0-t]

  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-∞]

  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

  To assess PK parameter of plasma 304 or rituximab：Observed maximum plasma concentration (Cmax)

  For 85 days

Secondary Outcomes (7)

• tmax

  For 85 days

• t1/2

  For 85 days

• MRT

  For 85 days

• Vz

  For 85 days

• CLz

  For 85 days

Study Arms (2)

experimental group

EXPERIMENTAL

304 injection.WILL be administered single dose IV in the patients with CD20 positive B cell NHL

Drug: 304 injection

control group

ACTIVE COMPARATOR

Rituximab will be administered single dose IV in the patients with CD20 positive B cell NHL.

Drug: rituximab injection

Interventions

304 injection DRUG

Monoclonal antibodies, 100mg/10ml per injection

experimental group

rituximab injection DRUG

100mg/10ml per injection ，manufactured by Roche

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (10)

The 307 Hospital of People's Liberation Army

Beijing, Beijing Municipality, 100071, China

RECRUITING

Beijing Luhe Hospital Capital Medical University

Beijing, Beijing Municipality, 101100, China

RECRUITING

Sun Yat-Sen University Cancer Hospital

Guangzhou, Guangdong, 510600, China

RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050010, China

RECRUITING

Affiliated Hospital of Hebei University

Baoding, Heibei, 071000, China

RECRUITING

Zhengzhou Central Hospital

Zhengzhou, Henan, 450007, China

RECRUITING

The First Affiliated Hospita of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Weihai Municipal Hospital

Weihai, Shandong, 264200, China

RECRUITING

Tianjin Medical University Cancer Institute &Hospital

Tianjing, Tianjing, 300060, China

RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, Zhejiang, 215000, China

RECRUITING

MeSH Terms

Interventions

Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Gang Tong

CONTACT

+86- 21- 84892211; tonggang@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: December 18, 2018
• Primary Completion: June 30, 2019
• Study Completion: October 31, 2019
• Last Updated: June 10, 2019

Record last verified: 2019-05

Locations

CN (10)