Trials / Unknown
UnknownNCT03902197
CD19 hsCAR-T for Refractory/Relapsed CD19+ B-ALL Patients
A Phase II Study of CD19 hsCAR-T for Refractory/Relapsed CD19+ B-ALL Patients Previously Treated With Cell Therapy
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Xuanwu Hospital, Beijing · Academic / Other
- Sex
- All
- Age
- 1 Year – 75 Years
- Healthy volunteers
- Not accepted
Summary
This Phase II study is to evaluate the efficacy and safety of a CD19-targeting humanized selective CAR-T (CD19 hsCAR-T) in refractory/relapsed CD19+ B-ALL leukemia patients who have no available curative treatment options, have a limited prognosis with currently available treatments, and were previously treated with a B cell directed cell therapy.
Detailed description
CD19+ B-ALL patients who have relapsed after murine-based CD19 CAR-T (CD19mCAR-T) treatment and/or have limited clinical response to CD19mCAR-T will be enrolled to receive CD19 hsCAR-T treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD19 hsCAR-T | CD19 hsCAR-T will be administered by I.V. infusion |
Timeline
- Start date
- 2019-04-22
- Primary completion
- 2021-12-31
- Completion
- 2023-12-21
- First posted
- 2019-04-03
- Last updated
- 2019-04-08
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03902197. Inclusion in this directory is not an endorsement.