The purpose of this study is to evaluate the safety and efficacy of SCTC21C in patients with CD38+ hematologic malignancies
This is a multicenter, open-label, phase I study aimed to evaluate the safety, tolerability, pharmacokinetics(PK), Pharmacodynamics(PD), preliminary anti-tumor activity and immunogenicity of SCTC21C in patients with relapsed or refractory CD38+ hematologic malignancies.The study includes Dose-finding stage and Dose-expansion stage. In Dose-finding stage, participants will be assigned to receive sequentially higher doses of SCTC21C ranging from 0.01 to 960mg. In Dose-expansion stage, total of at least 20 participants will be randomly assigned to receive two different doses of SCTC21C at a ratio of 1:1.All participants will receive the treatment until disease progression or unacceptable drug-related adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
SCTC21C is injected to the participants subcutaneously and is tentatively scheduled to be administered weekly for the first two cycles, once every 2weeks for cycle3-6, and once every 4 weeks thereafter until the occurrence of progressive disease
Beijing Chaoyang Hospital ,Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGTreatment-emergent adverse events (TEAEs) and serious adverse event (SAE)
To identify the incidence of TEAEs and SAE
Time frame: From the initiation of the first dose to the 45 days after the last dose
The incidence of dose limiting toxicities (dose-finding stage)
To identify the DLTs
Time frame: Cycle 1 (28 days)
Objective response rate (ORR)
ORR is defined as the proportion of patients who have an objective remission
Time frame: Throughout the study treatment,an average of 1 year
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