Trials / Completed
CompletedNCT03483688
A PhaseⅠb Study Evaluating Safety and Efficacy of C-CAR011 Treatment in B- NHL Subjects
A Phase Ⅰb Study Evaluating Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor T-cell (C-CAR011) Treatment in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Peking Union Medical College Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).
Detailed description
The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation; Lymphodepleting Chemotherapy), Treatment and Follow-up
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD19-directed CAR-T cells | CD19-directed CAR-T cells single infusion intravenously at a target dose of 0.5-5.0 x 10\^6 anti-CD19 CAR+ T cells/kg |
Timeline
- Start date
- 2018-03-06
- Primary completion
- 2019-12-10
- Completion
- 2020-01-10
- First posted
- 2018-03-30
- Last updated
- 2020-03-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03483688. Inclusion in this directory is not an endorsement.