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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
BTK inhibitor Orelabrutinib low dose or high dose; Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days.
Recombinant humanized monoclonal antibody MIL62 injection, 800mg or1000mg each time, Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days.
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Shijitan hospital, capital medical university
Beijing, Beijing Municipality, China
Dose limiting toxicity (DLT)(Dose escalation phase)
Safety observation indicator
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Maximum tolerated dose (MTD) (Dose escalation phase)
Safety observation indicator
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Recommended dose for phase 2 trials of two-drug combinations (RP2D) (Dose escalation phase)
Safety observation indicator
Time frame: At the end of Cycle 1 (each cycle is 28 days)
objective remission rate(ORR) (Dose expansion phase)
Efficacy observation indicator
Time frame: At the end of Cycle 30 (each cycle is 28 days)
objective remission rate(ORR)
Efficacy observation indicator
Time frame: At the end of Cycle 30 (each cycle is 28 days)
Area under the plasma concentration vs time curve(AUC)
pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Apparent half-life for designated elimination phases (t½)
pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment
Time frame: At the end of Cycle 6 (each cycle is 28 days)
The peak plasma concentration (Cmax)
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Cancer hospital, Chinese academy of medical sciences
Beijing, Beijing Municipality, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Henan Tumor Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Duration of remission(DOR)
Efficacy observation indicator
Time frame: 3 years after first treatment
Progression-free survival(PFS) in the treatment of R/R CD20+B cell lymphoma
Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of relapsed/refractory CD20+B cell lymphoma with 3-year progression-free survival
Time frame: 3 years after first treatment
overall survival(OS) in the treatment of R/R CD20+B cell lymphoma
Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of recurrent/refractory CD20+B cell lymphoma with 3-year overall survival
Time frame: 3 years after first treatment
Duration of remission(DOR) in the treatment of R/R NHL
Preliminary evaluation of remission duration of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma
Time frame: 3 years after first treatment
Progression-free survival(PFS) in the treatment of R/R NHL
Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma with 3-year progression-free survival
Time frame: 3 years after first treatment
overall survival(OS) in the treatment of R/R NHL
Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma with 3-year overall survival
Time frame: 3 years after first treatment