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CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.

NCT02132624 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-10-30

No results posted yet for this study

Summary

Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Conditions

  • B Cell Lymphoma
  • B Cell Leukemia

Interventions

BIOLOGICAL

Autologous 3rd generation CD19-targeting CAR T cells

Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.

Sponsors & Collaborators

  • Uppsala University Hospital

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • AFA Insurance

    collaborator INDUSTRY

  • Swedish Cancer Society

    collaborator OTHER

  • Uppsala University

    lead OTHER

Principal Investigators

  • Angelica Loskog, PhD · Uppsala University

  • Gunilla Enblad, MD, PhD · Uppsala University Hospital

  • Hans Hagberg, MD, PhD · Uppsala University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Sweden

Study Locations

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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 NCT02132624 on ClinicalTrials.gov