- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04304040
A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma
February 5, 2024 updated by: Beijing InnoCare Pharma Tech Co., Ltd.
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
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Anhui
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Bengbu, Anhui, China, 100000
- The First Affiliated Hospital of Bengbu Medical college
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Beijing
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Beijing, Beijing, China, 100000
- Beijing Hospital
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Beijing, Beijing, China, 100000
- Cancer Hospital, Chinese Academy of Medical Sciences
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Beijing, Beijing, China, 100000
- Beijing Shijitan Hospital, Capital Medical University
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Hebei
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Baoding, Hebei, China, 100000
- Affiliated Hospital of Hebei University
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Henan
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Zhengzhou, Henan, China, 100000
- Henan Tumor Hospital
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Hunan
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Changsha, Hunan, China, 100000
- Hunan Cancer Hospital
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Jiangsu
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Suzhou, Jiangsu, China, 100000
- First Affiliated Hospital of Soochow University
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Jilin
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Changchun, Jilin, China, 100000
- The First Hospital of Jilin University
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Tianjin
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Tianjin, Tianjin, China, 100000
- Tianjin People's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Single Arm
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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 injection, 800mg or1000mg each time, Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose limiting toxicity (DLT)(Dose escalation phase)
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
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Safety observation indicator
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At the end of Cycle 1 (each cycle is 28 days)
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Maximum tolerated dose (MTD) (Dose escalation phase)
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
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Safety observation indicator
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At the end of Cycle 1 (each cycle is 28 days)
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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)
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Safety observation indicator
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At the end of Cycle 1 (each cycle is 28 days)
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objective remission rate(ORR) (Dose expansion phase)
Time Frame: At the end of Cycle 30 (each cycle is 28 days)
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Efficacy observation indicator
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At the end of Cycle 30 (each cycle is 28 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective remission rate(ORR)
Time Frame: At the end of Cycle 30 (each cycle is 28 days)
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Efficacy observation indicator
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At the end of Cycle 30 (each cycle is 28 days)
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Area under the plasma concentration vs time curve(AUC)
Time Frame: At the end of Cycle 6 (each cycle is 28 days)
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pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment
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At the end of Cycle 6 (each cycle is 28 days)
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Apparent half-life for designated elimination phases (t½)
Time Frame: At the end of Cycle 6 (each cycle is 28 days)
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pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment
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At the end of Cycle 6 (each cycle is 28 days)
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The peak plasma concentration (Cmax)
Time Frame: At the end of Cycle 6 (each cycle is 28 days)
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pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment
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At the end of Cycle 6 (each cycle is 28 days)
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Duration of remission(DOR)
Time Frame: 3 years after first treatment
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Efficacy observation indicator
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3 years after first treatment
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Progression-free survival(PFS) in the treatment of R/R CD20+B cell lymphoma
Time Frame: 3 years after first treatment
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Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of relapsed/refractory CD20+B cell lymphoma with 3-year progression-free survival
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3 years after first treatment
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overall survival(OS) in the treatment of R/R CD20+B cell lymphoma
Time Frame: 3 years after first treatment
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Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of recurrent/refractory CD20+B cell lymphoma with 3-year overall survival
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3 years after first treatment
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Duration of remission(DOR) in the treatment of R/R NHL
Time Frame: 3 years after first treatment
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Preliminary evaluation of remission duration of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma
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3 years after first treatment
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Progression-free survival(PFS) in the treatment of R/R NHL
Time Frame: 3 years after first treatment
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Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma with 3-year progression-free survival
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3 years after first treatment
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overall survival(OS) in the treatment of R/R NHL
Time Frame: 3 years after first treatment
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Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma with 3-year overall survival
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3 years after first treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yuankai Shi, PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 28, 2020
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
March 5, 2020
First Submitted That Met QC Criteria
March 9, 2020
First Posted (Actual)
March 11, 2020
Study Record Updates
Last Update Posted (Actual)
February 7, 2024
Last Update Submitted That Met QC Criteria
February 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIL62-CT03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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