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CD19-CAR Immunotherapy for Childhood Acute Lymphoblastic Leukemia (ALL)

NCT01195480 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-05-17

No results posted yet for this study

Summary

The aim of this clinical trial is to evaluate the feasibility, safety and biological effect of adoptive transfer of CD19ζ chimaeric receptor transduced donor-derived EBV-specific cytotoxic T-lymphocytes (EBV-CTL) in patients with high-risk or relapsed B cell precursor ALL after allogeneic Haematopoietic Stem Cell Transplantation (HSCT).

Conditions

Interventions

GENETIC

donor-derived EBV-specific cytotoxic T-cells (EBV-CTL) transduced with the retroviral vector SFGalpha-CD19-CD3zeta

All patients will be treated at the same total dose level of 2 x 10\^8/m2

BIOLOGICAL

Irradiated donor-derived Lymphoblastoid Cell Line

The initial cohort of 5 patients (regardless of arm of study) will be treated as described. If transduced CTL infusion is safe in this initial cohort and real-time DNA PCR studies demonstrate that transduced CTL are undetectable in \> 50% of patients by 2 months post-infusion, the remaining 25 patients (in either arm of the study) will be treated as above but with an additional vaccination of CD19-zeta-transduced EBV-LCL infusion. Vaccination will consist of 3 doses of 5 x 10\^6 irradiated (70Gy) donor-derived EBV-lymphoblastoid cell line used to generate CTL and will be administered subcutaneously into the thigh (volume 0.3 ml) at day -2, week 4 and 8 post-transduced CTL infusion.

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Children with Leukaemia

    collaborator UNKNOWN

  • Department of Health, United Kingdom

    collaborator OTHER_GOV

  • JP Moulton Charitable Foundation

    collaborator OTHER

  • Deutsche Krebshilfe e.V., Bonn (Germany)

    collaborator OTHER

  • University College, London

    lead OTHER

Principal Investigators

  • Persis Amrolia, Professor · Great Ormond Street Hospital for Children NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Germany
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01195480 on ClinicalTrials.gov