CD20 Positive B Cell Non-Hodgkin's LymphomaPhase 1NCT03332121
B001 in Patients With CD20 Positive B-cell Non Hodgkin's Lymphoma
A Phase 1 study testing B001 in people with CD20 Positive B Cell Non-Hodgkin's Lymphoma, run by Shanghai Pharmaceuticals Holding Co., Ltd at 2 sites in China.
Trial summary
It's the first-in-human study of Recombinant Humanized Anti-CD20 Monoclonal Antibody for Injection (B001). The main purpose of this study is to explore the safety and tolerance of B001 for patients with CD20 positive B-cell non Hodgkin's lymphoma. It will also explore the PK/PD manner and ORR in this study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CD20 Positive B Cell Non-Hodgkin's Lymphoma
- What is being tested?
- B001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 22 Mar 2018to 28 Feb 2021
- 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
- Age of 18-75, male or female.
- Patients with the following histologically-documented hematologic malignancy: CD20 positive B-cell non Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), according to 2016 WHO Classification of Lymphoma.
- Patients with relapsed/refractory CD20 positive B cell NHL (including CLL/SLL )
- Life expectancy of at least 6 months.
- ECOG-PS score of 0-1.
- For patients of reproductive potential, pregnancy test should be negative 7 days before treatment , and use of a reliable means of contraception during the study and 12months after discontinuing treatment. Males should be willing to use barrier contraception during the study and 12months after discontinuing treatment.
- Provision of signed and dated ,written informed consent prior to any study specific procedures, sampling and analyses.
Who cannot join
- Serious blood, renal or hepatic function impairment:
- Absolute neutrophil count(ANC)<1.0*10^9/L（Except for those with bone marrow invasion）
- Lymphocyte Count(LYM)>50*10^9/L
- Haemoglobin(Hb)<70g/L（Except for those with bone marrow invasion）
- Platelet count(PLT)<50*10^9/L（Except for those with bone marrow invasion）
- Creatinine (Cr)>1.5xULN
Show all 35Show fewer
- Alanine transaminase (ALT)or Aspartate aminotransferase(AST)>2.5xULN
- Total bilirubin (TBIL)>2xULN
- Patients with any anti-tumor treatment (including steroid treatment) within 4 weeks or with any chronic unresolved toxicities from prior therapy greater than Grade 2 according to NCI-CTCAE 4.03.
- Rituximab or any other anti-CD20 monoclonal antibody treatment within 3 weeks.
- received blood transfusion and hemopoietic stimulating factor,eg. colony-stimulating factor (CSF)、Erythropoietin(EPO) within 2 weeks.
- Radiotherapy within 3 months.
- Major surgery within 28 days
- History of tumor vaccine treatment.
- Live-virus (live attenuated) vaccine treatment within 28 days
- High dose of steroid treatment (hydroprednisone >10mg/day or relevant dose of other drugs)
- Patients with history of hematopoietic stem cell transplantation or planning to receive hematopoietic stem cell transplantation within 3 months.
- Patients with history of Gastrointestinal perforation and/or fistula within 6 months.
- Lymphoma in CNS, ADIS related lymphoma
- Active infection by bacteria,virus,fungus which required hospitalization or severe infection required intravenous administration of antibiotics
- Concomitant severe disease including but not limited to:
- Known HIV or ADIS related disease
- Asthma or interstitial lung disease or severe COPD
- Myocardial infarction, unstable angina, Cardiovascular interventional surgery, Congestive heart failure(CHF; NYHA Grade II-IV), symptomatic or poorly controlled arrhythmia within 6 months before enrolling
- The systolic pressure ≥140mmHg,or diastolic pressure≥90mmHg post treatment.
- Acute or chronic hypotension(<90/60mmHg)
- History of toxic epidermal necrolysis or Stevens-Johnson syndrome
- Rheumatoid arthritis Granulomatous angiitis or microscopic polyangiitis
- Ileus or history of following disease: inflammatory bowel disease or extensive intestinal resection(extensive bowel resection or hemicolectomy, combining chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea.
- Previous or concomitant malignant, except basal-cell carcinoma or squamous cell carcinoma and/or cervical carcinoma in situ or effectively treated hematological malignancy and solid tumor that has been remission for more than 3 years and is considered to be cured.
- Any history may affect the study result: increasing dosing risk or affect lab values and Judgment by the investigator that the patient should not participate in the study,
- HBsAg positive; HBcAb positive and HBV-DNA≥upper limit of detection, HCV positive; HIV positive
- Allergy to humanized antibody or human-mouse chimeric antibody.
- Woman who are breast feeding or pregnant
- Judgment by the investigator that the patient should not participate in the study
Trial locations and contacts
2 sites in 1 country.
China2 sites
The second affiliated hospital of Guangzhou medical university
Guangzhou, Guangdong
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, Tianjin Municipality, 300020
About this study
Official title: Phase Ia Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Recombinant Humanized Anti-CD20 Monoclonal Antibody for Injection(B001)
It's the first-in-human study of Recombinant Humanized Anti-CD20 Monoclonal Antibody for Injection (B001). The main purpose of this study is to explore the safety and tolerance of B001 for patients with CD20 positive B-cell non Hodgkin's lymphoma. It will also explore the PK/PD manner and ORR in this study.
Read the detailed description
Phase I dose escalation study
- Being tested
- B001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B001Biological
4 times intravenous injection totally,dosing at Day1,Day35,Day56,Day77
| Study group | Role | What they receive |
|---|---|---|
| B001,B001 dose escalation | Experimental | 5 groups with different dose: 350mg/700mg/1000mg/1500mg/2000mg Receives: Biological: B001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of B001 as assessed by adverse reactions and events
Incidence and intensity of adverse events according to NCI CTCAE 4.03 associated with increasing doses of B001
Measured: 42 days
Secondary outcomes (4)
Concentration-time curve of B001
Measure the concentration of B001 in serum at different time point to get a concentration-time curve.
Measured: 112 days
PD results of B001
Measure the number of CD19 positive B cell in peripheral blood
Measured: 112 days
Immunogenicity of B001
Content analysis of anti-B001 antibody
Measured: 112 days
ORR of B001
Objective response rate according to Response Criteria for Lymphoma（not including PET）and CLL Response Criteria
Measured: 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start22 Mar 2018
- Primary completion30 Nov 2020
- Study completion28 Feb 2021
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 Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Shanghai Pharmaceuticals Holding Co., LtdThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lugui Qiu, Doctor, Principal investigator, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeJunyuan Qi, Doctor, Principal investigator, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332121
- Sponsor's protocol ID
- B001-101
- Status last verified
- Nov 2021
- First submitted
- 30 Oct 2017
- Last updated
- 15 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ia Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Recombinant Humanized Anti-CD20 Monoclonal Antibody for Injection(B001)
- ClinicalTrials.gov ID
- NCT03332121
- Acronym / sponsor ID
- B001-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 6 Nov 2017 (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.
It's the first-in-human study of Recombinant Humanized Anti-CD20 Monoclonal Antibody for Injection (B001). The main purpose of this study is to explore the safety and tolerance of B001 for patients with CD20 positive B-cell non Hodgkin's lymphoma. It will also explore the PK/PD manner and ORR in this study.
Detailed description
Phase I dose escalation study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B001,B001 dose escalation | Experimental | Biological: B0015 groups with different dose: 350mg/700mg/1000mg/1500mg/2000mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age of 18-75, male or female.
- Patients with the following histologically-documented hematologic malignancy: CD20 positive B-cell non Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), according to 2016 WHO Classification of Lymphoma.
- Patients with relapsed/refractory CD20 positive B cell NHL (including CLL/SLL )
- Life expectancy of at least 6 months.
- ECOG-PS score of 0-1.
Key exclusion criteria (35 listed)
- Serious blood, renal or hepatic function impairment:
- Patients with any anti-tumor treatment (including steroid treatment) within 4 weeks or with any chronic unresolved toxicities from prior therapy greater than Grade 2 according to NCI-CTCAE 4.03.
- Rituximab or any other anti-CD20 monoclonal antibody treatment within 3 weeks.
- received blood transfusion and hemopoietic stimulating factor,eg. colony-stimulating factor (CSF)、Erythropoietin(EPO) within 2 weeks.
- Radiotherapy within 3 months.
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 |
|---|---|---|
| B0014 times intravenous injection totally,dosing at Day1,Day35,Day56,Day77 | Biological | B001,B001 dose escalation |
Primary outcome
Safety of B001 as assessed by adverse reactions and events
Time frame: 42 days
Incidence and intensity of adverse events according to NCI CTCAE 4.03 associated with increasing doses of B001
4 secondary outcomes
Concentration-time curve of B001
Time frame: 112 days
PD results of B001
Time frame: 112 days
Immunogenicity of B001
Time frame: 112 days
ORR of B001
Time frame: 112 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 15 Nov 2021.
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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.
Lugui Qiu, Doctor principal investigator
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Junyuan Qi, Doctor principal investigator
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
2 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 B001 in people with CD20 Positive B Cell Non-Hodgkin's Lymphoma, run by Shanghai Pharmaceuticals Holding Co., Ltd at 2 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 7 inclusion and 35 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 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Safety of B001 as assessed by adverse reactions and events (time frame: 42 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 15 Nov 2021.