Trials / Completed
CompletedNCT04888468
Phase I Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
A Phase I Clinical Study of Anti-CD19 CAR-T Therapy (pCAR-19B) in the Treatment of CD19-positive Relapsed/Refractory B-ALL
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Chongqing Precision Biotech Co., Ltd · Industry
- Sex
- All
- Age
- 3 Years – 21 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase I clinical study to evaluate the safety and tolerability of pCAR-19B in patients with relapsed or refractory B-ALL, and to obtain the maximum tolerated dose of pCAR-19B and phase II Recommended dose.
Detailed description
This is a single-center, single-arm, open-label study. The study plans to set up 3 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 9-18 subjects with relapsed or refractory B-ALL.pCAR-19B will be infused to the subject by intravenous infusion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | pCAR-19B cells | Drug: pCAR-19B cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion. |
Timeline
- Start date
- 2019-11-05
- Primary completion
- 2021-06-29
- Completion
- 2021-09-01
- First posted
- 2021-05-17
- Last updated
- 2022-03-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04888468. Inclusion in this directory is not an endorsement.