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A Study of MIL62 Combined With ICP-022 for the Treatment of R/R CD20+B Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04304040
Recruitment Status : Not yet recruiting
First Posted : March 11, 2020
Last Update Posted : June 17, 2020
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 ICP-022 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: ICP-022 Drug: Recombinant humanized monoclonal antibody MIL62 injection Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 ICP-022 in the Treatment of Recurrent/Refractory CD20+B-cell Lymphoma
Estimated Study Start Date : June 20, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Single Arm Drug: ICP-022
BTK inhibitor ICP-022 100mg or 150mg once a day(QD). 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 ICP-022 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 ICP-022 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 ICP-022 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 ICP-022 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 ICP-022 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 FL [ Time Frame: 3 years after first treatment ]
    Preliminary evaluation of remission duration of MIL62 combined with ICP-022 in the treatment of Recurrent/refractory follicular lymphoma

  9. Progression-free survival(PFS) in the treatment of R/R FL [ Time Frame: 3 years after first treatment ]
    Preliminary evaluation of MIL62 combined with ICP-022 in the treatment of Recurrent/refractory follicular lymphoma with 3-year progression-free survival

  10. overall survival(OS) in the treatment of R/R FL [ Time Frame: 3 years after first treatment ]
    Preliminary evaluation of MIL62 combined with ICP-022 in the treatment of Recurrent/refractory follicular 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 (except for chronic lymphocytic leukemia/small lymphocytic lymphoma); Expansion stage: R/R Follicular Lymphoma(FL): histologically confirmed CD20 positive grade 1-3a follicular lymphoma with no tissue transformation. In case of suspected clinical transformation, biopsy of the suspected site is required to confirm no transformation
  3. Patients who have received at least one treatment regimen (with or without rituximab) without remission or progression after remission, or who are not tolerant to previous treatment
  4. Except for the splenic marginal region lymphoma, there was at least one two-dimensional measurable lesion (CT scan or MRI), namely, the longest diameter of the lymph node lesion was >1.5cm, the shortest diameter was >1cm, and the longest diameter of the extra-junction lesion was >1cm.
  5. Eastern cancer collaboration group(ECOG) physical status score: 0-2
  6. Laboratory tests performed within 7 days prior to the first acceptance of the study drug met the following criteria: 1) platelet count ≥75 x 109/L, neutrophils ≥1.5 x 109/L, hemoglobin ≥9g/dL, if accompanied by bone marrow invasion, platelet ≥50×109/L, neutrophils absolute value ≥1.0×109/L;2) glutamic oxalacetic transaminase (AST) or glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN;3) total bilirubin ≤ 1.5x Upper Limit of Normal(ULN); Renal creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault formula);4) prothrombin time (PT)/international normalized ratio(INR) ≤1.5 x ULN.
  7. Expected survival ≥6 months
  8. Sign a written informed consent.

Exclusion Criteria:

  1. Received any of the following anti-tumor treatments before the first study drug: (1) received any monoclonal antibody within 3 months;(2) received chemotherapy within 28 days;(3) received anti-tumor Chinese (herbal) drug treatment within 28 days (2 doses or more);(4) received radiotherapy within 42 days;(5) received other anti-tumor treatment within 28 days, such as BTK kinase inhibitor, Phosphatidylinositol -3- hydroxykinase(PI3K) inhibitor treatment;6. Received obinutuzumab (Gazyva, GA101) treatment within 12 months;
  2. Previous use of any anticancer vaccine
  3. Patients who had received hematopoietic stem cell transplantation within 3 months before the first administration or who planned to receive hematopoietic stem cell transplantation within 3 months
  4. Patients scheduled for major surgery within 28 days prior to initial administration or during the expected study period, except for diagnostic surgery
  5. Participated in other clinical trials within 28 days prior to first receiving the drug under study, or plan to participate in other clinical trials at the same time as this study
  6. Receiving prednisone treatment ≥20mg/ day or other corticosteroid treatment with the same dose as prednisone (if the dose can be kept stable below the dose level within 7 days before the baseline CT examination (<20mg/ day can be included);Patients who require warfarin or an equivalent vitamin K antagonist;
  7. During the study period, drugs with moderate or severe inhibition or strong induction of cytochrome CYP3A4 were taken together
  8. Subject has a history of any of the following diseases: central nervous system lymphoma or leukemia; Had other malignant tumors in the past 3 years, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that had received radical treatment;(3) progressive multifocal leukoencephalopathy (PML);(4) a history of stroke or intracranial hemorrhage within 6 months prior to receiving the study drug for the first time; Serious hemorrhagic diseases such as hemophilia A, hemophilia B, von Willebrand disease or spontaneous bleeding requiring blood transfusion or other medical intervention;
  9. Patients with active bacteria, viruses, fungi, mycobacteria, parasites or other infections (excluding nail bed fungal infections) and requiring intravenous antibiotic treatment before enrollment
  10. Impact testing scheme compliance or other serious results explain the poor control of the merger of the disease, including the clinical significance of cardiovascular disease (such as New York heart association class III or IV heart disease, myocardial within the past 6 months, obstruction or unstable type of arrhythmia, or unstable angina) or lung disease (including obstructive pulmonary disease (COPD) and history of bronchospasm);
  11. Toxicity of any previous anticancer treatment has not recovered to ≤1, except for hair loss
  12. A history of severe allergic reactions to humanized monoclonal antibodies or known allergies to any component of icp-022 or MIL62
  13. Inability to swallow research drugs, or the presence of conditions that significantly affect gastrointestinal function, such as malabsorption syndrome, gastric or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction
  14. Hepatitis b surface antigen (HBsAg) and/or hepatitis b core antibody (HBcAb) are positive and Hepatitis B Virus(HBV) DNA exceeds the normal range; Hepatitis b surface antigen (HBsAg) and/or hepatitis b core antibody (HBcAb) positive do not agree to regular DNA testing, or do not receive antiviral preventive treatment; Hepatitis c virus (HCV) antibody positive and HCV RNA positive patients; Human immunodeficiency virus (HIV) serum response was positive;
  15. Pregnant and lactating women; For women of childbearing age who have not undergone sterilization surgery: do not agree to use appropriate methods of contraception, such as oral contraceptives, intrauterine devices, barrier contraception or spermicide, during treatment and for at least 12 months after the last administration of the drug under study;
  16. For men not undergoing sterilization: do not agree to use the barrier method of contraception during the study period and for at least 12 months after the last administration of the study drug, and do not agree to request their spouse to use other methods of contraception, such as oral contraceptives, intrauterine devices, barrier methods of contraception or spermicide;
  17. 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, Beijing
Beijing Hospital
Beijing, Beijing, China, 100000
Beijing Shijitan hospital, capital medical university
Beijing, Beijing, China, 100000
Cancer hospital, Chinese academy of medical sciences
Beijing, Beijing, China, 100000
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: June 17, 2020
Last Verified: June 2020
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