A Randomized, Double-blind, Placebo-controlled Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTC21C in Subjects With Plasma Cell-driven Autoimmune Diseases

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in subjects with plasma cell-driven autoimmune diseases

Start Date01 Jan 2025

Sponsor / Collaborator

Sinocelltech Group Ltd.

NCT06252298

/ RecruitingPhase 1

A Phase I Clinical Study Evaluating the Safety and Efficacy of SCTC21C in Participants With CD38+ Hematologic Malignancies

The purpose of this study is to evaluate the safety and efficacy of SCTC21C in patients with CD38+ hematologic malignancies

Start Date28 Feb 2024

Sponsor / Collaborator

Sinocelltech Group Ltd.

CTR20254956

/ Not yet recruitingPhase 3

一项在新诊断的系统性轻链型淀粉样变性（NDSLCA）受试者中比较 SCTC21C 联合硼替佐米、环磷酰胺和地塞米松（S-VCd）对比硼替佐米、环磷酰胺和地塞米松（VCd）的安全性和有效性的 III 期、随机、开放、多中心研究

[Translation] A phase III, randomized, open-label, multicenter study comparing the safety and efficacy of SCTC21C in combination with bortezomib, cyclophosphamide, and dexamethasone (S-VCd) versus bortezomib, cyclophosphamide, and dexamethasone (VCd) in newly diagnosed patients with systemic light chain amyloidosis (NDSLCA).

主要研究目的：评估S-VCd治疗NDSLCA的安全性；评估S-VCd治疗NDSLCA的初步有效性。次要研究目的：评估 S-VCd 治疗 NDSLCA 受试者的其他疗效指标；评估 SCTC21C 的药代动力学特征；评估 SCTC21C 的免疫原性特征。

[Translation]

Primary study objectives: To evaluate the safety of S-VCd in treating NDSLCA; To evaluate the preliminary efficacy of S-VCd in treating NDSLCA. Secondary study objectives: To evaluate other efficacy endpoints of S-VCd in NDSLCA patients; To evaluate the pharmacokinetic characteristics of SCTC21C; To evaluate the immunogenicity of SCTC21C.

Start Date-

Sponsor / Collaborator

Shenzhou Cell Engineering Co. Ltd.

100 Clinical Results associated with SCT-C21

100 Translational Medicine associated with SCT-C21

100 Patents (Medical) associated with SCT-C21

100 Deals associated with SCT-C21

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Immunoglobulin Light-Chain Amyloidosis	Phase 3	China	Shenzhou Cell Engineering Co. Ltd.	12 Dec 2025
Multiple Myeloma	Phase 3	China	Shenzhou Cell Engineering Co. Ltd.	02 Dec 2025
Glomerulonephritis, IGA	Phase 2	China	Sinocelltech Group Ltd.	01 Jan 2025
CD38-Positive Hematologic Neoplasms	Phase 1	China	Sinocelltech Group Ltd.	28 Feb 2024
Hematologic Neoplasms	IND Approval	China	Shenzhou Cell Engineering Co. Ltd.	18 Jan 2024

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