Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05334823 | A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents | PHASE2 | RECRUITING | 100 | — | — | Jan 26, 2022 | Jul 1, 2025 | Jul 31, 2024 | 10 | China |
| NCT04888468 | Phase I Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents | PHASE1 | COMPLETED | 9 | — | — | Nov 5, 2019 | Sep 1, 2021 | Mar 18, 2022 | 1 | China |
Objective response rate includes CR, CRi.
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Dose-limiting toxicity after cell infusion
| Arm | Type | Description |
|---|---|---|
| pCAR-19B cells | EXPERIMENTAL | Infusion of pCAR-19B cells by dose of 0.6-2 x106 cells/kg |
| Name | Type | Description |
|---|---|---|
| pCAR-19B cells | BIOLOGICAL | Drug: pCAR-19B cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion. |
Inclusion Criteria: 1. The patient himself or his guardian agrees to participate in this clinical trial and signs the Informed Consent Form (ICF), indicating that he understands the purpose and procedures of this clinical trial and is willing to participate in the research; 2. Diagnosed with B-ALL，...