The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of SCTB35 and SCTB41 With or Without Chemotherapy in non-Hodgkin's lymphoma patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
SCTB35 will be subcutaneously administered at a dose as specified
SCTB41 will be IV administered at a dose as specified
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjing, Tianjing, China
Phase 1: dose limited toxicity (DLT)
To determine the maximum tolerated dose (MTD) and/or RP2D to be studied in the dose-expansion part
Time frame: Within 28 days of the first administration
Phase 2: Percentage of Participants Achieving Objective Response Rate (ORR)
ORR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria
Time frame: Up to approximately 3 years
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
Time frame: Up to approximately 3 years
Progression free survival (PFS)
Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Percentage of Participants Achieving CR
Percentage of participants who achieve a CR determined per Lugano criteria.
Time frame: Up to approximately 3 years
Duration of Response (DOR)
DOR is defined as the time from the first documented response (CR or PR) to disease progression or death, whichever occurs first.
Time frame: Up to approximately 3 years
Duration of Complete Response (DOCR)
DOCR is defined as the time from the first documented CR to disease progression or death, whichever occurs first.
Time frame: Up to approximately 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time to Response (TTR)
Time to response (TTR) is defined as the time from the start of therapy to the first documented CR or PR in patients who achieve an objective response
Time frame: Up to approximately 3 years
Time to Complete Response (TTCR)
TTCR is defined as the time from the start of therapy to the first documented CR among patients with a complete response.
Time frame: Up to approximately 3 years
Adverse Events
Treatment-emergent adverse events/serious adverse events/adverse events of special interest
Time frame: Up to approximately 3 years
Blood Concentrations of SCTB35 and SCTB41
Pharmacokinetics of SCTB35 and SCTB41 will be assessed using drug concentrations measured in plasma (or serum) at specified time points.
Time frame: Up to approximately 6 months
Anti-drug Antibodies of SCTB35 and SCTB41
Serum (or plasma) samples will be tested for the presence of anti-drug antibodies (ADAs) against SCTB35 and SCTB41
Time frame: Up to approximately 3 years