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To evaluate the efficacy and safety of S1904 in patients with relapsed or refractory CD19+B-ALL.
The primary objective: To evaluate the efficacy of S1904 in pediatric and adult subjects with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia.
The secondary objectives: To further characterize the efficacy and safety profiles of S1904 in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S1904 CD19 CAR-T | Experimental | Autologous CD19-targeting CAR T cells, dosage 1*10^6/kg, intravenous injection once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S1904 CD19 CAR-T | Biological | Autologous CD19-targeting CAR T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate after S1904 infusion [Effectiveness] | Independent Review Committee (IRC)-assessed ORR (CR + CRi) at Month 3 post-infusion, as per ALL Response Criteria. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojun Huang | Contact | 010-88325229 | xjhrm@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaojun Huang | Peking University People's Hospital | Principal Investigator |
| Hongsheng Zhou | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | China |
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| Ruidong Zhang |
| Beijing Children's Hospital |
| Principal Investigator |