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

Sponsor

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology (Other)

Overall Status

Recruiting

CT.gov ID

NCT05333302

Collaborator

(none)

Enrollment

Location

Arm

28.1

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
B-cell Acute Lymphoblastic Leukemia Lymphoblastic B-Cell Lymphoma	Biological: CD19 CAR-T-cells Drug: Tocilizumab	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 26, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CD19 CAR-T cells immunotherapy After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells	Biological: CD19 CAR-T-cells One dose of CD19 CAR-T cells (110e6 CAR+ T-cells/kg) by intravenous infusion. Drug: Tocilizumab* Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg). Other Names: Actemra

Arm

Intervention/Treatment

Experimental: CD19 CAR-T cells immunotherapy

After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells

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).

Other Names:

Actemra

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [1 month]
Adverse events will be graded according to the CTCAE v5.0

Secondary Outcome Measures

Objective Response Rate (ORR) (CR+CRi+CRm) [28 days after CAR-T cells infusion]
The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), complete molecular remission (CRm).
Overall survival (OS) [1 year]
The proportion of patients with overall survival
Events free survival (EFS) [1 year]
Time from CAR-T cells infusion to CR failure, relapse, or death.
Leukemia free survival (LFS) [1 year]
Time from achievement of CR/CRi/CRm to the time of relapse, death in remission, or last follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.