B-Cell LymphomaPhase 1NCT02945215
A Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients
A Phase 1 study testing IBI301 and Rituximab in people with B-Cell Lymphoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 12 sites in China.
Trial summary
Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- B-Cell Lymphoma
- What is being tested?
- IBI301 and Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 12 sitesChina
- Study dates
- 13 Dec 2016to 16 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CD20-positive B-cell lymphoma.
- 18 years to 65 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Signed an informed consent.
- Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy.
Who cannot join
- Participation in another interventional clinical trial in the past 28 days.
- Known allergic reactions against monoclonal antibody or rituximab.
- Rituximab and other anti-CD20 monoclonal antibody used in the past 4 months.
- Blood concentration of Rituximab>24ug/ml.
- HIV positive patients.
- HCV antigen and antibody positive.
- Acute and chronic hepatitis B virus infection.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing cancer hospital
Beijing, Beijing Municipality
Peking University third hospital
Beijing, Beijing Municipality
The 307th Hospital of Military Medical Sciences
Beijing, Beijing Municipality
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Xiangya Hospital of Central South University
Changsha, Hunan
West China Hospital,Sichuan University
Chengdu, Sichuan
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang
The First Affiliated Hospital Zhejiang University
Hangzhou, Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jiangsu province people's hospital
Nanjing, Jiangsu
Tianjin People's Hospital
Tianjin, Tianjin Municipality
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: A Multicenter, Randomized, Double-blinded, Parallel Controlled Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients
Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma
- Conditions
- B-Cell Lymphoma
- Being tested
- IBI301, Rituximab
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI301Drug
IBI301 375mg/㎡
RituximabDrug
Rituximab 375mg/㎡
| Study group | Role | What they receive |
|---|---|---|
| IBI301 | Experimental | Not described Receives: Drug: IBI301 |
| Rituximab | Active comparator | Not described Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf of IBI301 and rituximab
Measured: 91 days
Secondary outcomes (8)
Peak Plasma Concentration (Cmax)
Measured: 91 days
Percentage and absolute value of CD19+
Measured: 91 days
Percentage and absolute value of CD20+ B-cell
Measured: 91 days
Positive rate of ADA
Measured: 91 days
Positive rate of NAb
Measured: 91 days
Safety profiles
Including AE type、incidence rate、severity and drug- related
Measured: up to 1 year
Area under the plasma concentration versus time curve (AUC)
Measured: 91days
AUC（0-t） of IBI301 and rituximab
Measured: 91 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start13 Dec 2016
- Primary completion21 Mar 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) 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
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lugui Qiu, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945215
- Sponsor's protocol ID
- CIBI301A201
- Status last verified
- Jun 2020
- First submitted
- 24 Oct 2016
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded, Parallel Controlled Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients
- ClinicalTrials.gov ID
- NCT02945215
- Acronym / sponsor ID
- CIBI301A201
- Conditions
- B-Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 26 Oct 2016 (estimated)
- 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.
Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma
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 |
|---|---|---|
| IBI301 | Experimental | Drug: IBI301 |
| Rituximab | Active comparator | Drug: Rituximab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CD20-positive B-cell lymphoma.
- 18 years to 65 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Signed an informed consent.
- Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy.
Key exclusion criteria (7 listed)
- Participation in another interventional clinical trial in the past 28 days.
- Known allergic reactions against monoclonal antibody or rituximab.
- Rituximab and other anti-CD20 monoclonal antibody used in the past 4 months.
- Blood concentration of Rituximab>24ug/ml.
- HIV positive patients.
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 |
|---|---|---|
| IBI301IBI301 375mg/㎡ | Drug | IBI301 |
| RituximabRituximab 375mg/㎡ | Drug | Rituximab |
Primary outcome
AUC0-inf of IBI301 and rituximab
Time frame: 91 days
8 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: 91 days
Percentage and absolute value of CD19+
Time frame: 91 days
Percentage and absolute value of CD20+ B-cell
Time frame: 91 days
Positive rate of ADA
Time frame: 91 days
Positive rate of NAb
Time frame: 91 days
Safety profiles
Time frame: up to 1 year
Area under the plasma concentration versus time curve (AUC)
Time frame: 91days
AUC（0-t） of IBI301 and rituximab
Time frame: 91 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Lugui Qiu principal investigator
Chinese Academy of Medical Sciences
12 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 IBI301 and Rituximab in people with B-Cell Lymphoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 12 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-inf of IBI301 and rituximab (time frame: 91 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2020.