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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-finding and dose-expansion | Experimental | Dose-finding stage: The dose escalation in this study is pre-defined in nine dose groups. The dose escalation starts with 0.01mg and proceeds from low to high doses. Dose-expansion stage: Patients will be randomly assigned to receive different doses of SCTC21C at a ratio of 1:1. Doses of SCTC21C will be determined based on the data obtained in the Dose-finding stage. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCTC21C | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) and serious adverse event (SAE) | To identify the incidence of TEAEs and SAE | 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 | Cycle 1 (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR is defined as the proportion of patients who have an objective remission | Throughout the study treatment,an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Zhou | Contact | +86-10-58628288 | qiang_zhou@sinocelltech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital ,Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |