Trials / Unknown
UnknownNCT02782351
Humanized CAR-T Therapy for Treatment of B Cell Malignancy
Humanized CAR-T Therapy for Treatment of Recurrent or Refractory B Cell Malignancy by Targeting CD19
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Kai Lin Xu; Jun Nian Zheng · Academic / Other
- Sex
- All
- Age
- 3 Years
- Healthy volunteers
- Not accepted
Summary
The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a humanized scFv. All participants will receive autologous chimeric antigen receptor engineered T cells.
Detailed description
CD19 has been extensively evaluated as a therapeutic target for recurrent or refractory B cell malignancy by chimeric antigen receptor T cell therapy, the single chain antibody sequence (scFv) against CD19 derived from a mouse hybridoma was widely employed. However, the immunogenicity of the mouse scFv sequence might be one of the reasons that CAR-T cells cannot persist in vivo for long. In present study investigators replace the mouse-derived scFv with a a humanized one and evaluate its safety and efficacy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CAR-T | Patients will be infused with autologous CAR-T infusion in a dose escalating manner. |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2018-06-01
- Completion
- 2018-12-01
- First posted
- 2016-05-25
- Last updated
- 2017-08-04
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02782351. Inclusion in this directory is not an endorsement.