B-cell Lymphoma RecurrentPhase 1/2NCT04304040
A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma
A Phase 1/2 study testing Orelabrutinib and Recombinant humanized monoclonal antibody MIL62 injection in people with B-cell Lymphoma Recurrent and B-cell Lymphoma Refractory, run by Beijing InnoCare Pharma Tech Co., Ltd. at 10 sites in China.
Trial summary
Dose escalation and expansion phase I/IIa clinical study of recombinant humanized type II CD20 monoclonal antibody MIL62 injection combined with a novel selective Bruton Tyrosine Kinase(BTK) inhibitor Orelabrutinib in the treatment of recurrent/refractory CD20+B cell lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Lymphoma Recurrent, B-cell Lymphoma Refractory
- What is being tested?
- Orelabrutinib and Recombinant humanized monoclonal antibody MIL62 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 10 sitesChina
- Study dates
- 28 Jul 2020to 30 Dec 2025
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, gender not limited
- Dose escalation phase: Histologically confirmed CD20 positive B-cell non-Hodgkin's lymphoma; Expansion stage: R/R NHL Or histologically diagnosed CD20 positive chronic lymphocytic leukemia/small lymphocytic lymphoma;
- Dose escalation phase ：Patients who have received at least one treatment regimen Expansion stage：Patients who have received at least one to four treatment regimens with at least one regimen containing rituximab;
- Eastern cancer collaboration group(ECOG) physical status score: 0-2
- Laboratory tests performed within 7 days prior to the first acceptance of the study drug met the protocol criteria.
- Expected survival ≥6 months
- Sign a written informed consent.
Who cannot join
- Expansion stage: DLBCL transformed from follicular lymphoma, DLBCL with follicular lymphoma, and lymphomas with primary or central nervous system involvement.
- Received any of the anti-tumor treatments(note in the protocol) before the first study drug.
- Previous use of any anticancer vaccine.
- Patients who had received hematopoietic stem cell transplantation within 3 months before the first administration
- Patients scheduled for major surgery within 28 days prior to initial administration or during the expected study period.
- Patients who Is participating in other clinical trials or first administration less than 28 days after the end of the previous clinical trial.
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- Receiving prednisone treatment or other corticosteroid treatment with the same dose as prednisone ;Patients who require warfarin or an equivalent vitamin K antagonist;
- During the study period, drugs with moderate or severe inhibition or strong induction of cytochrome CYP3A4 were taken together;
- Subject has a history of any of the diseases note in the protocol;
- Patients with infections;
- Impact testing scheme compliance or other serious results explain the poor control of the merger of the disease(note in the protocol);
- Toxicity of any previous anticancer treatment has not recovered to ≤1, except for hair loss;
- A history of severe allergic reactions to humanized monoclonal antibodies or known allergies to any component of Orelabrutinib or MIL62;
- Inability to swallow research drugs, or the presence of conditions that significantly affect gastrointestinal function;
- Hepatitis b surface antigen (HBsAg) and/or hepatitis b core antibody (HBcAb) are positive ; Hepatitis c virus (HCV) antibody positive and HCV RNA positive patients; Human immunodeficiency virus (HIV) serum response was positive;
- Pregnant and lactating women; For women of childbearing age who have not undergone sterilization surgery: do not agree to use appropriate methods of contraception;
- For men not undergoing sterilization: do not agree to use the barrier method of contraception;
- Other circumstances considered inappropriate for the study by the investigator.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Affiliated Hospital of Hebei University
Baoding, Hebei, 100000
Beijing Hospital
Beijing, Beijing Municipality, 100000
Beijing Shijitan hospital, capital medical university
Beijing, Beijing Municipality, 100000
Cancer hospital, Chinese academy of medical sciences
Beijing, Beijing Municipality, 100000
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 100000
The First Hospital of Jilin University
Changchun, Jilin, 100000
Hunan Cancer Hospital
Changsha, Hunan, 100000
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 100000
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 100000
Henan Tumor Hospital
Zhengzhou, Henan, 100000
About this study
Official title: A Phase I/IIa Study on Dose-escalation and Extension of Recombinant Humanized Type II CD20 Monoclonal Antibody MIL62 Injection Combined With BTK Inhibitor Orelabrutinib in the Treatment of Recurrent/Refractory CD20+B-cell Lymphoma
Dose escalation and expansion phase I/IIa clinical study of recombinant humanized type II CD20 monoclonal antibody MIL62 injection combined with a novel selective Bruton Tyrosine Kinase(BTK) inhibitor Orelabrutinib in the treatment of recurrent/refractory CD20+B cell lymphoma
- Being tested
- Orelabrutinib, Recombinant humanized monoclonal antibody MIL62 injection
- Keywords
- CD20+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrelabrutinibDrug
BTK inhibitor Orelabrutinib low dose or high dose; Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days.
Recombinant humanized monoclonal antibody MIL62 injectionDrug
Recombinant humanized monoclonal antibody MIL62 injection, 800mg or1000mg each time, Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: Orelabrutinib; Drug: Recombinant humanized monoclonal antibody MIL62 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)(Dose escalation phase)
Safety observation indicator
Measured: At the end of Cycle 1 (each cycle is 28 days)
Maximum tolerated dose (MTD) (Dose escalation phase)
Safety observation indicator
Measured: At the end of Cycle 1 (each cycle is 28 days)
Recommended dose for phase 2 trials of two-drug combinations (RP2D) (Dose escalation phase)
Safety observation indicator
Measured: At the end of Cycle 1 (each cycle is 28 days)
objective remission rate(ORR) (Dose expansion phase)
Efficacy observation indicator
Measured: At the end of Cycle 30 (each cycle is 28 days)
Secondary outcomes (10)
objective remission rate(ORR)
Efficacy observation indicator
Measured: At the end of Cycle 30 (each cycle is 28 days)
Area under the plasma concentration vs time curve(AUC)
pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment
Measured: At the end of Cycle 6 (each cycle is 28 days)
Apparent half-life for designated elimination phases (t½)
pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment
Measured: At the end of Cycle 6 (each cycle is 28 days)
The peak plasma concentration (Cmax)
pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment
Measured: At the end of Cycle 6 (each cycle is 28 days)
Duration of remission(DOR)
Efficacy observation indicator
Measured: 3 years after first treatment
Progression-free survival(PFS) in the treatment of R/R CD20+B cell lymphoma
Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of relapsed/refractory CD20+B cell lymphoma with 3-year progression-free survival
Measured: 3 years after first treatment
overall survival(OS) in the treatment of R/R CD20+B cell lymphoma
Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of recurrent/refractory CD20+B cell lymphoma with 3-year overall survival
Measured: 3 years after first treatment
Duration of remission(DOR) in the treatment of R/R NHL
Preliminary evaluation of remission duration of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma
Measured: 3 years after first treatment
Progression-free survival(PFS) in the treatment of R/R NHL
Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma with 3-year progression-free survival
Measured: 3 years after first treatment
overall survival(OS) in the treatment of R/R NHL
Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma with 3-year overall survival
Measured: 3 years after first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start28 Jul 2020
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Lymphoma RecurrentStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, PhD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304040
- Sponsor's protocol ID
- MIL62-CT03
- Status last verified
- Feb 2024
- First submitted
- 5 Mar 2020
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study on Dose-escalation and Extension of Recombinant Humanized Type II CD20 Monoclonal Antibody MIL62 Injection Combined With BTK Inhibitor Orelabrutinib in the Treatment of Recurrent/Refractory CD20+B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04304040
- Acronym / sponsor ID
- MIL62-CT03
- Keywords
- CD20+
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 11 Mar 2020 (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.
Dose escalation and expansion phase I/IIa clinical study of recombinant humanized type II CD20 monoclonal antibody MIL62 injection combined with a novel selective Bruton Tyrosine Kinase(BTK) inhibitor Orelabrutinib in the treatment of recurrent/refractory CD20+B cell lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Orelabrutinib, Drug: Recombinant humanized monoclonal antibody MIL62 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years, gender not limited
- Dose escalation phase: Histologically confirmed CD20 positive B-cell non-Hodgkin's lymphoma; Expansion stage: R/R NHL Or histologically diagnosed CD20 positive chronic lymphocytic leukemia/small lymphocytic lymphoma;
- Dose escalation phase ：Patients who have received at least one treatment regimen Expansion stage：Patients who have received at least one to four treatment regimens with at least one regimen containing rituximab;
- Eastern cancer collaboration group(ECOG) physical status score: 0-2
- Laboratory tests performed within 7 days prior to the first acceptance of the study drug met the protocol criteria.
Key exclusion criteria (18 listed)
- Expansion stage: DLBCL transformed from follicular lymphoma, DLBCL with follicular lymphoma, and lymphomas with primary or central nervous system involvement.
- Received any of the anti-tumor treatments(note in the protocol) before the first study drug.
- Previous use of any anticancer vaccine.
- Patients who had received hematopoietic stem cell transplantation within 3 months before the first administration
- Patients scheduled for major surgery within 28 days prior to initial administration or during the expected study period.
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 |
|---|---|---|
| OrelabrutinibBTK inhibitor Orelabrutinib low dose or high dose; Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days. | Drug | Single Arm |
| Recombinant humanized monoclonal antibody MIL62 injectionRecombinant humanized monoclonal antibody MIL62 injection, 800mg or1000mg each time, Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days. | Drug | Single Arm |
Primary outcome
Dose limiting toxicity (DLT)(Dose escalation phase)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Safety observation indicator
Maximum tolerated dose (MTD) (Dose escalation phase)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Safety observation indicator
Recommended dose for phase 2 trials of two-drug combinations (RP2D) (Dose escalation phase)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Safety observation indicator
objective remission rate(ORR) (Dose expansion phase)
Time frame: At the end of Cycle 30 (each cycle is 28 days)
Efficacy observation indicator
10 secondary outcomes
objective remission rate(ORR)
Time frame: At the end of Cycle 30 (each cycle is 28 days)
Area under the plasma concentration vs time curve(AUC)
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Apparent half-life for designated elimination phases (t½)
Time frame: At the end of Cycle 6 (each cycle is 28 days)
The peak plasma concentration (Cmax)
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Duration of remission(DOR)
Time frame: 3 years after first treatment
Progression-free survival(PFS) in the treatment of R/R CD20+B cell lymphoma
Time frame: 3 years after first treatment
overall survival(OS) in the treatment of R/R CD20+B cell lymphoma
Time frame: 3 years after first treatment
Duration of remission(DOR) in the treatment of R/R NHL
Time frame: 3 years after first treatment
Progression-free survival(PFS) in the treatment of R/R NHL
Time frame: 3 years after first treatment
overall survival(OS) in the treatment of R/R NHL
Time frame: 3 years after first treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- 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.
Yuankai Shi, PhD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Orelabrutinib and Recombinant humanized monoclonal antibody MIL62 injection in people with B-cell Lymphoma Recurrent and B-cell Lymphoma Refractory, run by Beijing InnoCare Pharma Tech 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 7 inclusion and 18 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 7 Feb 2024. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Dose limiting toxicity (DLT)(Dose escalation phase) (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 4 primary outcomes in all. 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 7 Feb 2024.