Trials / Completed
CompletedNCT03232619
CD19-CART Treatment for ALL
Safety and Efficacy Evaluation of CD19-CART Treatment for Refractory or Recurrent ALL
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Bioray Laboratories · Industry
- Sex
- All
- Age
- 6 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of refractory or recurrent ALL.
Detailed description
Chimeric antigen receptor T cell (CART) is a kind of engineered immunotherapy by transferring an artificial antigen binding receptor and also intercellular co-stimulating molecules into T cells. This kind of engineered T cells gains the ability to recognize antigen specific tumor cells and initiate the killing process in a HLA-independent way. CD19 is the specific cellular marker of B lineage acute leukemia (B-ALL), thus CD19-CART will be efficient in treating B lineage ALL. The investigators have constructed two kinds of CD19-CART. One is equipped with a murine CD19 scFv (single-chain variable fragmentt), while the other with a humanized scFv. This study aims to evaluate the safety and efficacy of both murine and humanized CD19-CART in treating refractory or recurrent ALL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD19 CART | Patients will get one course of CART treatment with the dose of 0.5-5\*10\~6/KgBW. |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2020-05-06
- Completion
- 2020-09-15
- First posted
- 2017-07-28
- Last updated
- 2020-09-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03232619. Inclusion in this directory is not an endorsement.