Trials / Not Yet Recruiting
Not Yet RecruitingNCT05381181
Safety and Efficacy Evaluation of Next-generation CD19-UCART
Clinical Study of the Safety and Efficacy of Next-generation Universal CD19 Chimeric Antigen Receptor T Cells in the Treatment of Relapsed or Refractory B Cell Malignancies
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Bioray Laboratories · Industry
- Sex
- All
- Age
- 1 Year – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of Next-generation CD19-UCART in patients with relapsed or refractory B-cell hematological malignancies.
Detailed description
CD19-UCART is a kind of "off-the-shelf" product originated from health donor's PBMC. This is an open-label, single arm study to evaluate the safety and anti- tumor efficacy of Next-generation CD19-UCART in the treatment of relapsed or refractory B-cell hematological malignancies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD19-UCART | A conditioning therapy with cyclophosphamide and fludarabine will be conducted before CD19-UCART injection. VP16 can be added to the conditioning therapy. |
Timeline
- Start date
- 2023-12-20
- Primary completion
- 2024-05-30
- Completion
- 2026-05-03
- First posted
- 2022-05-19
- Last updated
- 2023-01-27
Source: ClinicalTrials.gov record NCT05381181. Inclusion in this directory is not an endorsement.