B-cell LymphomasPhase 1NCT03218072
A Study to Evaluate Safety, Tolerability, PK and PD of HLX01 in Patients With CD20-positive B-cell Lymphomas
A Phase 1 study testing HLX01 in people with B-cell Lymphomas, run by Shanghai Henlius Biotech.
Trial summary
To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a potential rituximab biosimilar) in patients with CD20-positive B-cell lymphomas. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- B-cell Lymphomas
- What is being tested?
- HLX01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2014to 31 Jan 2015
- 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
- 18 years ≤ aged ≤ 65 years, male or female;
- having histologically confirmed diagnosis of relapsed/refractory CD20-positive B-cell lymphomas which needed consolidation therapy;
- Eastern Cooperative Oncology Group (ECOG) performance status≤1 and life expectancy ≥3 months;
- providing signed and dated informed consents.
Who cannot join
- Usage of rituximab or other anti-CD20 monoclonal antibody within 2 years before enrollment;
- usage of hematopoietic cytokines within 1 week before enrollment, e.g. granulocyte colony stimulating factor (G-CSF);
- recent major surgery (excluding diagnostic surgery) within the past 8 weeks;
- peripheral nervous system diseases or central nervous system diseases;
- inadequate hematologic function met any of the following at screening: white blood cell count <3.0×109/L, absolute neutrophil count (lobocyte and rhabdocyte) <1.5×109/L, platelet count <100×109/L, hemoglobin <90 g/L, for patients with bone marrow involvement, absolute neutrophil count (lobocyte and rhabdocyte) <1.0×109/L, platelet count <75×109/L, hemoglobin <80 g/L;
- inadequate liver function met any of the following at screening: total bilirubin>1.5×the upper limit of normal range (ULN), ALT or AST>2.0×ULN, alkaline phosphatase (ALP)>3.0×ULN;
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- abnormal renal function (serum creatinine>1.5×ULN);
- abnormal thyroid function (TSH< lower limit of normal or > upper limit of normal with clinical significance judged by investigators);
- positive test result(s) for serum HIV antigen or antibody;
- seropositivity of HBsAg, or seropositivity of HBcAb and HBV DNA>ULN; seropositivity of Anti HCV antibody;
- history of herpes zoster and left with sequelae or latent infection;
- other serious disease which may restrict subjects to participate in the trial (such as ongoing active infection, uncontrolled diabetes mellitus, severe cardiac insufficiency or angina pectoris, gastric ulcer, active autoimmune disease, etc.);
- pregnancy or breast feeding female, or not willing to use effective contraceptive measures during the study;
- allergic constitution, or known allergic to components of rituximab or other anti-CD20 monoclonal antibody;
- history of alcoholism or drug abuse; participation in other clinical trials within 3 months before enrollment;
- not suitable for enrollment at investigator's discretion.
About this study
Official title: A Phase Ia, Multi-centers, Open-label, Dose-escalation Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HLX01 (a Potential Rituximab Biosimilar) in Patients With CD20-positive B-cell Lymphomas
To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a potential rituximab biosimilar) in patients with CD20-positive B-cell lymphomas.
Read the detailed description
This was a phase Ia, multicenter, open-label, dose-escalation clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics of HLX01 injection in patients with CD20-positive B-cell lymphomas.
- Conditions
- B-cell Lymphomas
- Being tested
- HLX01
- 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.
HLX01Drug
a potential rituximab biosimilar
| Study group | Role | What they receive |
|---|---|---|
| HLX01 250 mg/m2 | Experimental | HLX01 250 mg/m2 administrated intravenously Receives: Drug: HLX01 |
| HLX01 375 mg/m2 | Experimental | HLX01 375 mg/m2 administrated intravenously Receives: Drug: HLX01 |
| HLX01 500 mg/m2 | Experimental | HLX01 500 mg/m2 administrated intravenously Receives: Drug: HLX01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs
The type, severity and incidence of adverse events
Measured: From First infusion to Day 90
SAEs
Thetype, severity and incidence of SAEs
Measured: From First infusion to Day 90
Secondary outcomes (6)
AUC0-inf
Area under the serum concentration-time curve from time 0 extrapolated to infinity
Measured: From First administration to Day 90
Cmax
Maximum serum concentration
Measured: From First administration to Day 90
t1/2
terminal half-life
Measured: From First administration to Day 90
CD19 positive B cells
The count of CD19 positive in peripheral blood
Measured: From First administration to Day 90
CD20 positive B cells
The count of CD20 positive in peripheral blood
Measured: From First administration to Day 90
Antidrug antibodies of HLX01
The concentration of anti-HLX01 in serum
Measured: From First administration to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start4 May 2014
- Primary completion31 Jan 2015
- Study completion31 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B-cell LymphomasStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218072
- Sponsor's protocol ID
- HLX01-NHL01
- Status last verified
- May 2022
- First submitted
- 7 Jul 2017
- Last updated
- 9 May 2022
- Results posted
- No
Publications
Shi Y, Zhang Q, Han X, Qin Y, Ke X, Su H, Liu L, Fu J, Jin J, Feng J, Hong X, Zhang X, Wu D, Jiang B, Dong X. Phase 1 studies comparing safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a rituximab biosimilar) to reference rituximab in Chinese patients with CD20-positive B-cell lymphoma. Chin J Cancer Res. 2021 Jun 30;33(3):405-416. doi: 10.21147/j.issn.1000-9604.2021.03.11.
PubMed 34321836
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia, Multi-centers, Open-label, Dose-escalation Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HLX01 (a Potential Rituximab Biosimilar) in Patients With CD20-positive B-cell Lymphomas
- ClinicalTrials.gov ID
- NCT03218072
- Acronym / sponsor ID
- HLX01-NHL01
- Conditions
- B-cell Lymphomas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 4 May 2014 (actual)
- Primary completion
- 31 Jan 2015 (actual)
- Study completion
- 31 Jan 2015 (actual)
- First posted
- 14 Jul 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.
To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a potential rituximab biosimilar) in patients with CD20-positive B-cell lymphomas.
Detailed description
This was a phase Ia, multicenter, open-label, dose-escalation clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics of HLX01 injection in patients with CD20-positive B-cell lymphomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HLX01 250 mg/m2 | Experimental | Drug: HLX01HLX01 250 mg/m2 administrated intravenously |
| HLX01 375 mg/m2 | Experimental | Drug: HLX01HLX01 375 mg/m2 administrated intravenously |
| HLX01 500 mg/m2 | Experimental | Drug: HLX01HLX01 500 mg/m2 administrated intravenously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years ≤ aged ≤ 65 years, male or female;
- having histologically confirmed diagnosis of relapsed/refractory CD20-positive B-cell lymphomas which needed consolidation therapy;
- Eastern Cooperative Oncology Group (ECOG) performance status≤1 and life expectancy ≥3 months;
- providing signed and dated informed consents.
Key exclusion criteria (16 listed)
- Usage of rituximab or other anti-CD20 monoclonal antibody within 2 years before enrollment;
- usage of hematopoietic cytokines within 1 week before enrollment, e.g. granulocyte colony stimulating factor (G-CSF);
- recent major surgery (excluding diagnostic surgery) within the past 8 weeks;
- peripheral nervous system diseases or central nervous system diseases;
- inadequate hematologic function met any of the following at screening: white blood cell count <3.0×109/L, absolute neutrophil count (lobocyte and rhabdocyte) <1.5×109/L, platelet count <100×109/L, hemoglobin <90 g/L, for patients with bone marrow involvement, absolute neutrophil count (lobocyte and rhabdocyte) <1.0×109/L, platelet count <75×109/L, hemoglobin <80 g/L;
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 |
|---|---|---|
| HLX01a potential rituximab biosimilar | Drug | HLX01 250 mg/m2, HLX01 375 mg/m2, HLX01 500 mg/m2 |
Primary outcome
AEs
Time frame: From First infusion to Day 90
The type, severity and incidence of adverse events
SAEs
Time frame: From First infusion to Day 90
Thetype, severity and incidence of SAEs
6 secondary outcomes
AUC0-inf
Time frame: From First administration to Day 90
Cmax
Time frame: From First administration to Day 90
t1/2
Time frame: From First administration to Day 90
CD19 positive B cells
Time frame: From First administration to Day 90
CD20 positive B cells
Time frame: From First administration to Day 90
Antidrug antibodies of HLX01
Time frame: From First administration to Day 90
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 9 May 2022.
- Results publication: PubMed 34321836Shi Y, Zhang Q, Han X, Qin Y, Ke X, Su H, Liu L, Fu J, Jin J, Feng J, Hong X, Zhang X, Wu D, Jiang B, Dong X. Phase 1 studies comparing safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a rituximab biosimilar) to reference rituximab in Chinese patients with CD20-positive B-cell lymphoma. Chin J Cancer Res. 2021 Jun 30;33(3):405-416. doi: 10.21147/j.issn.1000-9604.2021.03.11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX01 in people with B-cell Lymphomas, run by Shanghai Henlius Biotech.
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 4 inclusion and 16 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 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
AEs (time frame: From First infusion to Day 90). The study lists 2 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 NCT03218072, which also lists 1 linked publication.
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 9 May 2022.