Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma

B-cell Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333302
• Other study ID #: CD19CAR-T_LL_children
• Status: Recruiting
• Phase: Phase 1
• Start date: October 26, 2020
• Est. completion date: June 2023

Study information

• Verified date: February 2023
• Source: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
• Contact: Elena Lukoyko, MD
• Phone: +375291643075
• Email: lenalukojko[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 30 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• primary immunodeficiencies or genetic syndromes;
• neurologic diseases;
• autoimmune diseases or polyallergie;
• transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion;
• GvHD grade 2-4;
• uncontrolled systemic infection;
• hypoxia (Sp02<90%)
• severe hepatic dysfunction: ALT or AST >=3x upper limit of normal for age;
• renal dysfunction: serum creatinine level >=3x upper limit of normal for age;
• positive serology for human immunodeficiency virus (HIV), active hepatite C or B;
• pregnancy.

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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).

Locations

Country	Name	City	State
Belarus	Belarussian Research Center for Pediatric Oncology, Hematology and Immunology	Minsk	Minsk Region

Sponsors (1)

Lead Sponsor	Collaborator
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Adverse events will be graded according to the CTCAE v5.0	1 month
Secondary	Objective Response Rate (ORR) (CR+CRi+CRm)	The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), complete molecular remission (CRm).	28 days after CAR-T cells infusion
Secondary	Overall survival (OS)	The proportion of patients with overall survival	1 year
Secondary	Events free survival (EFS)	Time from CAR-T cells infusion to CR failure, relapse, or death.	1 year
Secondary	Leukemia free survival (LFS)	Time from achievement of CR/CRi/CRm to the time of relapse, death in remission, or last follow-up.	1 year