B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and toxicity of epcoritamab as a monotherapy and when combined with standard of care therapy \[Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or Rituximab and lenalidomide (R2)\] in adult participants in China with B-Cell Non-Hodgkin Lymphoma. Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of B-Cell Non-Hodgkin Lymphoma. Study doctors put the participants in groups called treatment arms. A monotherapy of epcoritamab and two different combination of epcoritamab with standard of care therapy (R-CHOP or R2) will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. Approximately 66 adult participants with B-Cell Non-Hodgkin Lymphoma will be enrolled in the study in approximately 21 sites in China. In the monotherapy arm (Cohort 1), participants will receive subcutaneous epcoritamab in 28-day cycles. In the combination arms (Cohorts 2 and 3), participants in Cohort 2 will receive subcutaneous epcoritamab with standard of care therapy (R-CHOP) in 21-day cycles followed by 28-day cycles, participants in Cohort 3 will receive subcutaneous epcoritamab with standard of care therapy (R2) in 28-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Subcutaneous Injection (SC)
IV Injection
Intravenous (IV) Infusion
IV Infusion
IV Infusion
Oral; Tablet
Oral; Capsule
The Fifth Medical Center of PLA General Hospital /ID# 230520
Beijing, Beijing Municipality, China
Peking University Third Hospital /ID# 228138
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital /ID# 231890
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center /ID# 228033
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital /ID# 228028
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 227916
Guangzhou, Guangdong, China
Henan Cancer Hospital /ID# 228772
Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 231221
Wuhan, Hubei, China
Hunan Cancer Hospital /ID# 231859
Changsha, Hunan, China
The First Affiliated Hospital of Soochow University /ID# 228024
Suzhou, Jiangsu, China
...and 8 more locations
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Best Overall Response (BOR)
Best overall response (BOR) is defined as the percentage of participants in Cohort 1 Part 2 third line plus (3L) R/R DLBCL who achieved best overall response of complete response (CR) or partial response (PR) by Lugano 2014 criteria as assessed by independent review committee (IRC).
Time frame: Up to Approximately 5 Years
Cohort 1 Part 1, Cohort 2, and Cohort 3: Number of Incidence of Dose-Limiting Toxicities (DLT)
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Time frame: Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Percentage of Participants with Complete Remission (CR)
CR is defined as the absence of lymphoma determined by Lugano 2014 criteria as assessed by IRC.
Time frame: Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Number of Participants with Progression-free survival (PFS)
PFS is defined as the time in months from the first dose of study drug to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.
Time frame: Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Overall survival (OS)
OS is defined for Cohort 1 epcoritamab monotherapy participants, as the time in months from first dose of epcoritamab to death from any cause.
Time frame: Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Duration of response (DOR)
DOR is defined for participants who achieved best overall response of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.
Time frame: Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Time-to-response (TTR)
TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by IRC.
Time frame: Up to Approximately 5 Years
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