CD19 T-CAR for Treatment of Children and Young Adults With r/r B-ALL

Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Study ID
NCT03467256
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Acute Lymphocytic Leukemia, Pediatric
  • B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
3 Months - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Chimeric Antigen Receptor T-Cell Therapy — BIOLOGICAL
    anti-CD19 chimeric antigen receptor - transduced T-cell given IV
  • Fludarabine — DRUG
    given IV
  • Cyclophosphamide — DRUG
    given IV
  • Tocilizumab — DRUG
    given IV
  • Cytarabine — DRUG
    given IV
  • Etoposide — DRUG
    given IV
  • Dexamethasone — DRUG
    given IV

Study Details

The purpose of this study is to evaluate the safety and efficiency of autologous CD19 CAR-T lymphocytes in a cohort of pediatric and young adult patients with relapsed /refractory B-lineage acute lymphoblastic leukemia

Key Dates

Start date
May 14, 2018
Status verified
Feb 2023
Primary completion
Oct 15, 2020
Completion
Oct 15, 2025

Study Design

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

Arms

  • Experimental: experimental
    Patients will receive lymphodepleting chemotherapy, one hour prior to infusion of CAR T-cells patients will receive tocilizumab IV 8 mg/kg (max 800 mg) over 1 hour. Patients then receive CD19-CAR T cells IV on day 0.

Primary Outcome Measure

Incidence of grade 3-5 SAE occurring within 30 days of CD19CAR T-cell infusion [ Time Frame: 1 month ]

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