Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults
Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 30
Healthy Volunteers: f
View:
• CD19+ relapsed or refractory lymphoblastic leukemia/lymphoma;
• Karnofsky or Lansky performance scale greater or equal to 70;
• T-cells count in peripheral blood \>150 cells/µL;
• Written informed consent.
Locations
Other Locations
Belarus
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
RECRUITING
Minsk
Contact Information
Primary
Elena Lukoyko, MD
lenalukojko@gmail.com
+375291643075
Backup
Aleksandr Meleshko, PhD
meleshko@tut.by
+375296940023
Time Frame
Start Date: 2020-10-26
Estimated Completion Date: 2025-06
Participants
Target number of participants: 10
Treatments
Experimental: CD19 CAR-T cells immunotherapy
After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells
Related Therapeutic Areas
Sponsors
Leads: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology