Clinical Research Directory

Early Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of STR-P005

This study is a single-center, single-arm, open-label, investigator-initiated early exploratory clinical trial designed to evaluate the safety and efficacy of STR-P005 in subjects with relapsed/refractory autoimmune diseases. The study will employ the traditional "3+3" dose escalation model, setting up 3 dose groups: Amg/kg, Bmg/kg, C mg/kg. Dose Group 1 will serve as the starting dose, with two cohorts A and B within this group aimed at optimizing the dosing frequency of STR-P005. Cohort A will receive dosing every 3 days (Q3D), on D1, D4, D7 (3 doses) constituting one cycle, which can be repeated for 2 cycles. Cohort B will receive dosing every 4 days (Q4D), on D1, D4 (2 doses) constituting one cycle, which can be repeated for 2 cycles. Based on the preliminary safety data, efficacy information, and PK/PD parameters obtained from Cohorts 1A and 1B, the investigators will select the superior regimen and escalate sequentially to Dose Groups 2 and 3. If no MTD is found after dose escalation through the 3 groups, based on all available preliminary safety data, efficacy information, and PK/PD parameters, higher doses may be added for further exploration of safety and efficacy after discussion by the SRC.

A Study of LUCAR-G79 in Subjects With Relapsed/Refractory Autoimmune Diseases

This is a prospective, single-arm, open-label and dose-escalation Investigator Initialed study to evaluate LUCAR-G79 in adult subjects with relapsed/refractory autoimmune diseases.

Early Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Effectiveness of STR-P005

This is a single-center, single-arm, open-label, investigator-initiated early exploratory clinical trial designed to evaluate the safety and efficacy of STR-P005 in participants with relapsed/refractory autoimmune diseases. The study will employ a traditional "3+3" dose-escalation design, with 3 dose groups: XXmg/kg, XXmg/kg, XXmg/kg. Dose Group 1 is the starting dose. This group includes two cohorts, A and B, to optimize the dosing frequency of STR-P005. Cohort A will receive doses Q3D (once every 3 days) on Days 1, 4, 7 (3 doses per cycle), for up to 2 cycles. Cohort B will receive doses Q4D (once every 4 days) on Days 1, 4 (2 doses per cycle), for up to 2 cycles. Based on preliminary safety, efficacy, PK/PD data from Cohorts 1A and 1B, the superior regimen will be selected for escalation to Dose Groups 2 and 3. If no optimal dose is identified after escalating through the 3 dose groups, additional higher doses may be explored after SRC discussion based on all accumulated preliminary safety, efficacy, and PK/PD data to further evaluate the safety and efficacy of STR-P005.

A Clinical Study of AFN50 in the Treatment of Autoimmune Diseases

This study is a single-arm, open-label, single-centre exploratory clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of AFN50 Injection in adult patients with B-cell-mediated refractory/replapased autoimmune diseases.

A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases

This is a prospective, single-arm, open-label and dose-escalation Investigator Initialed study to evaluate LUCAR-DKS1 in adult subjects with relapsed/refractory autoimmune diseases.

CAR-T in Subjects With Relapsed/Refractory Autoimmune Disease

In this study, CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19 to treat autoimmune disease. The CAR-T cells were provided by Shenzhen Cell Valley. A study published in the New England Journal of Medicine provides strong evidence for the therapeutic potential of CD19 CAR-T therapy in autoimmune diseases. The study enrolled 15 participants, including eight with severe SLE, three with idiopathic inflammatory myositis, and four with systemic sclerosis. The median follow-up was 15 months (4 to 29 months). Data from the clinical trial showed that all patients with SLE had a remission of DORIS, all patients with idiopathic inflammatory myositis had an ACR-EULAR major clinical response, all patients with systemic sclerosis had a decrease in the EUSTAR activity index score, and all patients discontinued immunosuppressive therapy completely. The investigators look forward to expanding the use of CAR-T cells in relapsed/refractory autoimmune diseases through this safety and efficacy clinical study and greatly enhancing the quality of life for these patients.