Trials / Unknown
UnknownNCT02842138
Autologous CD19 CAR T Cells in Relapsed or Refractory B-cell Lymphoma
A Safety and Efficacy Study of Autologous T Cells Engineered to Express Chimeric Antigen Receptor Targeting CD19 in Patients With Relapsed or Refractory B-cell Lymphoma
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- Peking University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a single arm, open-label, one center, dose escalation clinical study to determine the safety and efficacy of infusion of autologous T cells expressing CD19-redirected Chimeric Antigen Receptor (CD19 CAR T) in adult patients with relapsed or refractory CD19 positive B-cell lymphoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | autologous anti-CD19 CAR T cells | Patients will receive a three-day regimen of chemotherapy consisting of fludarabine and cyclophosphamide aimed to deplete the lymphocytes. Four days after lymphodepletion, patients are intravenously infused autologous anti-CD19 CAR T cells. A prescribed CAR T cell dose will be intravenously infused to patient in a three-day split-dose regimen (day0,30%; day1, 30%; day2, 40%). |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2018-02-28
- Completion
- 2019-08-01
- First posted
- 2016-07-22
- Last updated
- 2019-02-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02842138. Inclusion in this directory is not an endorsement.