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A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT04304040
Recruitment Status : Recruiting
First Posted : March 11, 2020
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
Beijing InnoCare Pharma Tech Co., Ltd.

Brief 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

Condition or disease Intervention/treatment Phase
B-cell Lymphoma Recurrent B-cell Lymphoma Refractory Drug: Orelabrutinib Drug: Recombinant humanized monoclonal antibody MIL62 injection Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 28, 2020
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Single Arm Drug: Orelabrutinib
BTK inhibitor Orelabrutinib low dose or high dose; Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days.

Drug: Recombinant humanized monoclonal antibody MIL62 injection
Recombinant humanized monoclonal antibody MIL62 injection, 800mg or1000mg each time, Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days.




Primary Outcome Measures :
  1. Dose limiting toxicity (DLT)(Dose escalation phase) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Safety observation indicator

  2. Maximum tolerated dose (MTD) (Dose escalation phase) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Safety observation indicator

  3. 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

  4. objective remission rate(ORR) (Dose expansion phase) [ Time Frame: At the end of Cycle 30 (each cycle is 28 days) ]
    Efficacy observation indicator


Secondary Outcome Measures :
  1. objective remission rate(ORR) [ Time Frame: At the end of Cycle 30 (each cycle is 28 days) ]
    Efficacy observation indicator

  2. Area under the plasma concentration vs time curve(AUC) [ Time Frame: At the end of Cycle 6 (each cycle is 28 days) ]
    pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment

  3. Apparent half-life for designated elimination phases (t½) [ Time Frame: At the end of Cycle 6 (each cycle is 28 days) ]
    pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment

  4. The peak plasma concentration (Cmax) [ Time Frame: At the end of Cycle 6 (each cycle is 28 days) ]
    pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment

  5. Duration of remission(DOR) [ Time Frame: 3 years after first treatment ]
    Efficacy observation indicator

  6. Progression-free survival(PFS) in the treatment of R/R CD20+B cell lymphoma [ Time Frame: 3 years after first treatment ]
    Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of relapsed/refractory CD20+B cell lymphoma with 3-year progression-free survival

  7. overall survival(OS) in the treatment of R/R CD20+B cell lymphoma [ Time Frame: 3 years after first treatment ]
    Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of recurrent/refractory CD20+B cell lymphoma with 3-year overall survival

  8. Duration of remission(DOR) in the treatment of R/R NHL [ Time Frame: 3 years after first treatment ]
    Preliminary evaluation of remission duration of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma

  9. Progression-free survival(PFS) in the treatment of R/R NHL [ Time Frame: 3 years after first treatment ]
    Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma with 3-year progression-free survival

  10. overall survival(OS) in the treatment of R/R NHL [ Time Frame: 3 years after first treatment ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years, gender not limited
  2. 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;
  3. 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;
  4. Eastern cancer collaboration group(ECOG) physical status score: 0-2
  5. Laboratory tests performed within 7 days prior to the first acceptance of the study drug met the protocol criteria.
  6. Expected survival ≥6 months
  7. Sign a written informed consent.

Exclusion Criteria:

  1. Expansion stage: DLBCL transformed from follicular lymphoma, DLBCL with follicular lymphoma, and lymphomas with primary or central nervous system involvement.
  2. Received any of the anti-tumor treatments(note in the protocol) before the first study drug.
  3. Previous use of any anticancer vaccine.
  4. Patients who had received hematopoietic stem cell transplantation within 3 months before the first administration
  5. Patients scheduled for major surgery within 28 days prior to initial administration or during the expected study period.
  6. Patients who Is participating in other clinical trials or first administration less than 28 days after the end of the previous clinical trial.
  7. Receiving prednisone treatment or other corticosteroid treatment with the same dose as prednisone ;Patients who require warfarin or an equivalent vitamin K antagonist;
  8. During the study period, drugs with moderate or severe inhibition or strong induction of cytochrome CYP3A4 were taken together;
  9. Subject has a history of any of the diseases note in the protocol;
  10. Patients with infections;
  11. Impact testing scheme compliance or other serious results explain the poor control of the merger of the disease(note in the protocol);
  12. Toxicity of any previous anticancer treatment has not recovered to ≤1, except for hair loss;
  13. A history of severe allergic reactions to humanized monoclonal antibodies or known allergies to any component of Orelabrutinib or MIL62;
  14. Inability to swallow research drugs, or the presence of conditions that significantly affect gastrointestinal function;
  15. 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;
  16. Pregnant and lactating women; For women of childbearing age who have not undergone sterilization surgery: do not agree to use appropriate methods of contraception;
  17. For men not undergoing sterilization: do not agree to use the barrier method of contraception;
  18. Other circumstances considered inappropriate for the study by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304040


Contacts
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Contact: Yuankai Shi, PhD 010-67781331 syuankaipumc@126.com

Locations
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China, Anhui
The First Affiliated Hospital of Bengbu Medical College Recruiting
Bengbu, Anhui, China, 100000
Contact: Yanli Yang         
China, Beijing
Beijing Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Hui Liu         
Beijing Shijitan hospital, capital medical university Recruiting
Beijing, Beijing, China, 100000
Contact: xinghe wang         
Contact: weijing Zhang         
Principal Investigator: weijing Zhang         
Principal Investigator: Xinghe Wang         
Cancer hospital, Chinese academy of medical sciences Recruiting
Beijing, Beijing, China, 100000
Contact: Yuankai Shi, PhD    010-67781331    syuankaipumc@126.com   
China, Hebei
Affiliated Hospital of Hebei University Recruiting
Baoding, Hebei, China, 100000
Contact: Aimin Zhang         
China, Henan
Henan Tumor Hospital Recruiting
Zhengzhou, Henan, China, 100000
Contact: Yufu Li         
China, Hunan
Hunan Cancer Hospital Recruiting
Changsha, Hunan, China, 100000
Contact: Hui Zhou         
China, Jiangsu
First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 100000
Contact: Zhengming, Jin         
China, Jilin
The First Hospital of Jilin University Recruiting
Changchun, Jilin, China, 100000
Contact: Sujun Gao         
China, Tianjin
Tianjin People's Hospital Recruiting
Tianjin, Tianjin, China, 100000
Contact: Huaqing Wang         
Sponsors and Collaborators
Beijing InnoCare Pharma Tech Co., Ltd.
Investigators
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Principal Investigator: Yuankai Shi, PhD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Beijing InnoCare Pharma Tech Co., Ltd.
ClinicalTrials.gov Identifier: NCT04304040    
Other Study ID Numbers: MIL62-CT03
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing InnoCare Pharma Tech Co., Ltd.:
CD20+
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs