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
Study ID
NCT05333302
Phase
PHASE1
Status
Recruiting
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Conditions

  • B-cell Acute Lymphoblastic Leukemia
  • Lymphoblastic B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • CD19 CAR-T-cells — BIOLOGICAL
    One dose of CD19 CAR-T cells (1\*10e6 CAR+ T-cells/kg) by intravenous infusion.
  • Tocilizumab — DRUG
    Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).

Study Details

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.

Key Dates

Start date
Oct 26, 2020
Status verified
Aug 2024
Primary completion
Dec 31, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: 1 month ]

Central Contacts

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