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This study is a single-arm, open-label clinical study designed to evaluate the safety and tolerability of QT-019B in subjects with refractory SLE and to determine the RD. The study has two phases: dose escalation and dose expansion, with a planned enrollment of 18-24 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QT-019B Cell Injection | Experimental | The study will begin by enrolling the first subject in Dose A (1×106/kg), followed by a 14-day interval before enrolling the following subjects at this dose level. Upon completing the DLT observation period for Dose Group A: 1) if no DLTs are observed, the SRC may choose to proceed to Dose Group B (3×106/kg). 2) if one DLT is noted, the SRC may opt to add 3 more subjects to Dose A, and if a second DLT occurs, the SRC may consider ending the study or reducing the dose. 3) if two DLTs are observed at Dose A, the SRC may decide to terminate the study or reduce the dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QT-019B Cell Injection | Drug | The study will begin by enrolling the first subject in Dose A (1×106/kg), followed by a 14-day interval before enrolling the following subjects at this dose level. Upon completing the DLT observation period for Dose Group A: 1) if no DLTs are observed, the SRC may choose to proceed to Dose Group B (3×106/kg). 2) if one DLT is noted, the SRC may opt to add 3 more subjects to Dose A, and if a second DLT occurs, the SRC may consider ending the study or reducing the dose. 3) if two DLTs are observed at Dose A, the SRC may decide to terminate the study or reduce the dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Dose-Limiting Toxicities (DLTs) | A Dose-Limiting Toxicity (DLT) is defined as a specific set of severe (Grade 3 or higher) treatment-related toxicities (including hematological and non-hematological toxicities) that occur during the DLT observation period. DLTs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. This measure is used to determine the Recommended Dose (RD). | Within 28 days following QT-019B administration. |
| Number of Subjects with Adverse Events (AEs) | This includes the frequency and severity of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs), and Serious Adverse Events (SAEs). Severity will be assessed using NCI-CTCAE v5.0. This includes systemic toxicities and cell-therapy-specific events such as Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). | From QT-019B administration through Day 28 (Acute Safety Period). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) Score. | The Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) is a validated clinical instrument used to assess disease activity in SLE. The scale ranges from a minimum score of 0 to a maximum score of 105. Higher scores indicate a worse outcome (greater disease activity). | Day 28, 60, 90, 180, 270, 360, 450, 540, 630, and 730. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhijiang Wang | Contact | +86 151 5712 6379 | zhijiang.wang@qihanbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Mengtao Li, PhD | Peking Union Medical College Hospital | Principal Investigator |
| Zhu Chen, PhD | The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Ustc Anhui Provincial Hospital | Recruiting | Hefei | Anhui | China |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Change from Baseline in Physician's Global Assessment (PGA) Score | The Physician Global Assessment (PGA) is a visual analog scale used by the investigator to rate the patient's overall disease activity. The scale ranges from a minimum of 0 (no disease activity) to a maximum of 3 (severe disease activity). Higher scores indicate a worse outcome. | Day 28, 60, 90, 180, 270, 360, 450, 540, 630, and 730. |
| Change from Baseline in British Isles Lupus Assessment Group 2004 (BILAG-2004) Index. | The British Isles Lupus Assessment Group 2004 (BILAG-2004) index measures disease activity across 9 organ systems. For the purpose of numerical analysis, category scores (A-E) are often converted to a total numerical score. The scale ranges from a minimum of 0 to a maximum of 72. Higher scores indicate a worse outcome (higher disease activity). | Day 28, 60, 90, 180, 270, 360, 450, 540, 630, and 730 |
| Peak Concentration (Cmax) of QT-019B in Peripheral Blood | The maximum observed concentration of QT-019B (CAR-transgene copies) in peripheral blood measured via qPCR/ddPCR after administration. This represents the peak expansion of the cell product. | From Day 0 through Day 28 post-administration. |
| Area Under the Concentration-Time Curve (AUC 0-28d) of QT-019B | The total systemic exposure of QT-019B in peripheral blood over the first 28 days post-infusion, calculated using the linear trapezoidal rule. | From Day 0 through Day 28 post-administration. |
| Time to Reach Peak Concentration (Tmax) of QT-019B | The time (in days) from the start of QT-019B infusion to the observation of the maximum concentration (Cmax) in peripheral blood. | From Day 0 through Day 28 post-administration. |
| Qiubai Li, PhD |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Principal Investigator |
| Ting Zhang, PhD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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