Status:
ACTIVE_NOT_RECRUITING
A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
B-cell Lymphoma Recurrent
B-cell Lymphoma Refractory
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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 stage：Patients 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
- 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.
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04304040
Start Date
July 28 2020
End Date
December 30 2025
Last Update
February 7 2024
Active Locations (10)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 100000
2
Beijing Hospital
Beijing, Beijing Municipality, China, 100000
3
Beijing Shijitan hospital, capital medical university
Beijing, Beijing Municipality, China, 100000
4
Cancer hospital, Chinese academy of medical sciences
Beijing, Beijing Municipality, China, 100000