Trials / Unknown
UnknownNCT04204161
A Clinical Study of CAR-T Cells Treatment for Children With CD19+/CD22+ R/R ALL and Lymphoma
A Clinical Study Evaluating the Safety and Efficacy of CAR-T19/CAR-T22 Treatment for Children With CD19 Positive Relapse or Refractory Childhood Acute Lymphoblastic Leukemia and Lymphoma
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Shenzhen BinDeBio Ltd. · Industry
- Sex
- All
- Age
- 1 Month – 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a single arm, open-label, uni-center, phase I study . In this study, Children withCD19+/CD22+ R/R B-cell acute lymphoblastic leukemia or lymphoma will be treated with CAR-T19/CAR-T22 Immunotherapy to determine the safety and efficacy of treatment.
Conditions
- Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood
- Refractory B-cell Acute Lymphoblastic Leukemia, Childhood
- Relapsed/Refractory B-cell Lymphoma, Childhood
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CAR-T19/CAR-T22 | According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.The recommand dose is 1x10\^5/kg-2.5x10\^8/kg . |
Timeline
- Start date
- 2019-10-08
- Primary completion
- 2021-10-30
- Completion
- 2024-10-08
- First posted
- 2019-12-18
- Last updated
- 2021-02-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04204161. Inclusion in this directory is not an endorsement.