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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    120
  • sponsor
    Beijing InnoCare Pharma Tech Co., Ltd.
Updated on 19 August 2021

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

Details
Condition B-cell Lymphoma Recurrent, B-cell Lymphoma Refractory
Treatment orelabrutinib, Recombinant Humanized Monoclonal Antibody MIL62 Injection
Clinical Study IdentifierNCT04304040
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
Last Modified on19 August 2021

Eligibility

Yes No Not Sure

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 stagePatients 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
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