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
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
Drug | Synonyms | Arms |
---|
Orelabrutinib | | Single Arm |
Recombinant humanized monoclonal antibody MIL62 injection | | Single 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
Name | Type | Description | Interventions |
---|
Single Arm | Experimental | | - 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
Last Updated
August 9, 2021