Clinical Trials /

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

NCT04304040

Description:

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

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: MIL62-CT03
  • NCT ID: NCT04304040

Conditions

  • B-cell Lymphoma Recurrent
  • B-cell Lymphoma Refractory

Interventions

DrugSynonymsArms
OrelabrutinibSingle Arm
Recombinant humanized monoclonal antibody MIL62 injectionSingle Arm

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Single ArmExperimental
  • Orelabrutinib
  • Recombinant humanized monoclonal antibody MIL62 injection

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose limiting toxicity (DLT)(Dose escalation phase)
Time Frame:At the end of Cycle 1 (each cycle is 28 days)
Safety Issue:
Description:Safety observation indicator

Secondary Outcome Measures

Measure:objective remission rate(ORR)
Time Frame:At the end of Cycle 30 (each cycle is 28 days)
Safety Issue:
Description:Efficacy observation indicator
Measure:Area under the plasma concentration vs time curve(AUC)
Time Frame:At the end of Cycle 6 (each cycle is 28 days)
Safety Issue:
Description:pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment
Measure:Apparent half-life for designated elimination phases (t½)
Time Frame:At the end of Cycle 6 (each cycle is 28 days)
Safety Issue:
Description:pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment
Measure:The peak plasma concentration (Cmax)
Time Frame:At the end of Cycle 6 (each cycle is 28 days)
Safety Issue:
Description:pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment
Measure:Duration of remission(DOR)
Time Frame:3 years after first treatment
Safety Issue:
Description:Efficacy observation indicator
Measure:Progression-free survival(PFS) in the treatment of R/R CD20+B cell lymphoma
Time Frame:3 years after first treatment
Safety Issue:
Description:Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of relapsed/refractory CD20+B cell lymphoma with 3-year progression-free survival
Measure:overall survival(OS) in the treatment of R/R CD20+B cell lymphoma
Time Frame:3 years after first treatment
Safety Issue:
Description:Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of recurrent/refractory CD20+B cell lymphoma with 3-year overall survival
Measure:Duration of remission(DOR) in the treatment of R/R NHL
Time Frame:3 years after first treatment
Safety Issue:
Description:Preliminary evaluation of remission duration of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma
Measure:Progression-free survival(PFS) in the treatment of R/R NHL
Time Frame:3 years after first treatment
Safety Issue:
Description:Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma with 3-year progression-free survival
Measure:overall survival(OS) in the treatment of R/R NHL
Time Frame:3 years after first treatment
Safety Issue:
Description:Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma with 3-year overall survival

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Beijing InnoCare Pharma Tech Co., Ltd.

Trial Keywords

  • CD20+

Last Updated

August 9, 2021