This is a Phase I clinical study designed to evaluate the safety, tolerability, and pharmacokinetics, and preliminary efficacy of SCTB35 monotherapy, an bispecific antibody, in patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma.
Age ≥ 18 years
Histologically or cytologically confirmed CD20+ mature B-cell neoplasm
De novo or transformed diffuse large B-cell lymphoma (DLBCL)
High-grade B-cell lymphoma (HGBCL)
Any prior therapy with an bispecific antibody of the same class
Eligible for high dose chemotherapy with hematopoietic stem cell transplantation (HSCT)
Known central nervous system (CNS) involvement by lymphoma
Cervical carcinoma of Stage Ib or less
Single group
SCTB35 injection
DrugSCTB35 will be subcutaneously administered at a dose as specified in the respective dose-escalation cohorts. Then, the RP2D and another appropriate dose of SCTB35 will be applied for the dose-expansion cohorts.
Dose-escalation part: dose limited toxicity (DLT)
To determine the maximum tolerated dose (MTD) and/or RP2D to be studied in the dose-expansion part
Dose-escalation part: incidence rate of adverse event (AE)
To evaluate the incidence rates of treatment emergent adverse event (TEAE), treatment-related TEAE (TRAE), serious adverse event (SAE), adverse event with special interest (AESI)
Dose-expansion part: objective response rate (ORR)
ORR is defined as the percentage of patients achieving complete response (CR) or partial response (PR) as determined by the investigator according to the Lugano Criteria 2014
Dose-escalation part: ORR
ORR is defined as the percentage of patients achieving CR or PR as determined by the investigator according to the Lugano Criteria 2014
Dose-escalation part: CR rate (CRR)
CR rate is defined as the percentage of patients with CR as determined by the investigator according to the Lugano Criteria 2014
Dose-escalation part: best of overall response (BOR)
BOR is defined as the percentage of patients achieving best response from the first dose to first documented disease progression (PD) or new anticancer therapy, whichever occurs first, as determined by the investigator according to the Lugano Criteria 2014
Dose-escalation part: duration of response (DOR)
DOR is defined as the time from first documented objective response to PD or death due to any cause, whichever occurs first, as determined by the investigator according to the Lugano Criteria 2014
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