Trials / Recruiting
RecruitingNCT05333302
Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Belarusian Research Center for Pediatric Oncology, Hematology and Immunology · Academic / Other
- Sex
- All
- Age
- 1 Year – 30 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to estimate the safety and the efficacy of CAR- T cells immunotherapy for children/young adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.
Detailed description
Locally manufactured second generation autologous CD19 CAR-T cells are used for immunotherapy. Protocol treatment includes lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one CAR-T cells intravenous infusion with tocilizumab premedication.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD19 CAR-T-cells | One dose of CD19 CAR-T cells (1\*10e6 CAR+ T-cells/kg) by intravenous infusion. |
| DRUG | Tocilizumab | Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg). |
Timeline
- Start date
- 2020-10-26
- Primary completion
- 2024-12-01
- Completion
- 2025-06-01
- First posted
- 2022-04-18
- Last updated
- 2024-08-28
Locations
1 site across 1 country: Belarus
Source: ClinicalTrials.gov record NCT05333302. Inclusion in this directory is not an endorsement.