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

Phase 1

Recruiting

• Conditions: Lymphoblastic B-Cell Lymphoma; B-cell Acute Lymphoblastic Leukemia
• Interventions: Biological: CD19 CAR-T-cells; Drug: Tocilizumab

• Registration Number: NCT05333302
• Lead Sponsor: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

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.

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 Timeline

• Study Start: 2020-10-26
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD19 CAR-T cells immunotherapy	CD19 CAR-T-cells	After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells
CD19 CAR-T cells immunotherapy	Tocilizumab	After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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).
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.
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.

Trial Locations

Locations (1)

Belarussian Research Center for Pediatric Oncology, Hematology and Immunology; 🇧🇾 Minsk, Minsk Region, Belarus