CD20 Positive B Cell NHLPhase 1NCT03980379

Pharmacokinetics, Efficacy and Safety of the 304 Injection

A Phase 1 study testing 304 injection and rituximab injection in people with CD20 Positive B Cell NHL, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 10 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: CD20 Positive B Cell NHL
What is being tested?: 304 injection and rituximab injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 10 sitesChina
Study dates: 18 Dec 2018to 31 Oct 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 19Show fewer

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

Trial locations and contacts

10 sites in 1 country.

Gang Tong contact

+86- 21- 84892211

tonggang@3sbio.com

City, postcode or hospital

Sites recruiting now only

10 sites in 1 country

China10 sites, 10 recruiting

Affiliated Hospital of Hebei University
Baoding, Heibei, 071000
aimin Zang, 03125983056, hdfygcp@163.com
aimin Zang
Recruiting
The 307 Hospital of People's Liberation Army
Beijing, Beijing Municipality, 100071
Hang Su, 13701396736, suhang307@126.com
hang Su
Recruiting
Beijing Luhe Hospital Capital Medical University
Beijing, Beijing Municipality, 101100
dong Yan, 13621308215, yd15yt88@163.com
dong Yan
Recruiting
Sun Yat-Sen University Cancer Hospital
Guangzhou, Guangdong, 510600
huiqiang huang, 020-87343535, huanghq@sysucc.org.cn
huiqiang huang
Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050010
Lihong Liu, 13831177920;, 13831177920@163.com
Lihong Liu
Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Zhejiang, 215000
zhixiang Zhuang, 13951106391, 13951106391@139.com
zhixiang Zhuang
Recruiting
Tianjin Medical University Cancer Institute &Hospital
Tianjing, Tianjing, 300060
Lanfang Li, 18622221613, Lilanfangmeng@163.com
Lanfang Li
Recruiting
Weihai Municipal Hospital
Weihai, Shandong, 264200
xiuzhi Deng, 18660377358, 18660377358@126.com
xiuzhi Deng
Recruiting
Zhengzhou Central Hospital
Zhengzhou, Henan, 450007
shanyong Yi, 15516991321, yisy2001@126.com
shanyong Yi
Recruiting
The First Affiliated Hospita of Zhengzhou University
Zhengzhou, Henan, 450052
mingzhi Zhang, 13838565629, mingzhi_zhang@126.com
mingzhi Zhang
Recruiting

Other trials in China

About this study

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

Read the 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.

Conditions: CD20 Positive B Cell NHL
Being tested: 304 injection, rituximab injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

304 injectionDrug
Monoclonal antibodies, 100mg/10ml per injection
rituximab injectionDrug
100mg/10ml per injection ，manufactured by Roche

Study groups in NCT03980379
Study group	Role	What they receive
experimental group	Experimental	304 injection.WILL be administered single dose IV in the patients with CD20 positive B cell NHL Receives: Drug: 304 injection
control group	Active comparator	Rituximab will be administered single dose IV in the patients with CD20 positive B cell NHL. Receives: Drug: rituximab injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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])
Measured: 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-∞])
Measured: For 85 days
Cmax
To assess PK parameter of plasma 304 or rituximab：Observed maximum plasma concentration (Cmax)
Measured: For 85 days

Secondary outcomes (7)

tmax
To assess PK parameter of plasma 304 or rituximab：Time to Cmax (tmax)
Measured: For 85 days
t1/2
To assess PK parameter of plasma 304 or rituximab：Elimination half-life (t1/2)
Measured: For 85 days
MRT
To assess PK parameter of plasma 304 or rituximab：Mean residence time (MRT)
Measured: For 85 days
Vz
To assess PK parameter of plasma 304 or rituximab：Apparent volume of distribution(Vz)
Measured: For 85 days
CLz
To assess PK parameter of plasma 304 or rituximab：apparent clearance (CLz)
Measured: For 85 days
ADA
To evaluate the incidence of anti-304 and anti-rituximab antibodies
Measured: Up to 9 months
Adverse events
To evaluate the adverse events (incidence, severity, outcome, causality with the investigational drug, etc.).
Measured: Up to 85 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 201831 Oct 2019

First posted10 Jun 2019
Study start18 Dec 2018
Primary completion30 Jun 2019 (estimated)
Study completion31 Oct 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CD20 Positive B Cell NHLStudies of the same condition, open and under way.
More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03980379
Sponsor's protocol ID: SSGJ-304-NHL-I-02
Status last verified: May 2019
First submitted: 6 Jun 2019
Last updated: 10 Jun 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

Gang Tong

+86- 21- 84892211

tonggang@3sbio.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
The Safety, Tolerability, and Efficacy of IBR900 Cell Injection in Relapsed/Refractory B-cell Non Hodgkin Lymphoma
Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Active, not recruitingPhase 1
First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228
Lymphoma
Active, not recruitingPhase 1
A Phase 1 Study of TRS005 in Patients With R/R CD20-positive B-NHL.
CD20-positive B-cell Non-Hodgkin Lymphoma
RecruitingPhase 1
A Study of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma
B-cell Non Hodgkin Lymphoma

All CD20 Positive B Cell NHL trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Pharmacokinetics, Efficacy, and Safety of 304 Injection Compared With Rituximab in B Cell Non-Hodgkin's Lymphoma
ClinicalTrials.gov ID: NCT03980379
Acronym / sponsor ID: SSGJ-304-NHL-I-02
Conditions: CD20 Positive B Cell NHL
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
Study start: 18 Dec 2018 (actual)
Primary completion: 30 Jun 2019 (estimated)
Study completion: 31 Oct 2019 (estimated)
First posted: 10 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
experimental group	Experimental	Drug: 304 injection304 injection.WILL be administered single dose IV in the patients with CD20 positive B cell NHL
control group	Active comparator	Drug: rituximab injectionRituximab will be administered single dose IV in the patients with CD20 positive B cell NHL.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
304 injectionMonoclonal antibodies, 100mg/10ml per injection	Drug	experimental group
rituximab injection100mg/10ml per injection ，manufactured by Roche	Drug	control group

Primary outcome

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])
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-∞])
Cmax
Time frame: For 85 days
To assess PK parameter of plasma 304 or rituximab：Observed maximum plasma concentration (Cmax)

7 secondary outcomes

tmax
Time frame: For 85 days
t1/2
Time frame: For 85 days
MRT
Time frame: For 85 days
Vz
Time frame: For 85 days
CLz
Time frame: For 85 days
ADA
Time frame: Up to 9 months
Adverse events
Time frame: Up to 85 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
Individual participant dataSharing planned: Undecided

Related trials for CD20 Positive B Cell NHL

RecruitingPhase 1
The Safety, Tolerability, and Efficacy of IBR900 Cell Injection in Relapsed/Refractory B-cell Non Hodgkin Lymphoma
Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Active, not recruitingPhase 1
First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228
Lymphoma
Active, not recruitingPhase 1
A Phase 1 Study of TRS005 in Patients With R/R CD20-positive B-NHL.
CD20-positive B-cell Non-Hodgkin Lymphoma
RecruitingPhase 1
A Study of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma
B-cell Non Hodgkin Lymphoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gang Tong contact

+86- 21- 84892211

tonggang@3sbio.com

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 304 injection and rituximab injection in people with CD20 Positive B Cell NHL, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gang Tong (+86- 21- 84892211, tonggang@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC [0-t] (time frame: For 85 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03980379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.