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Completed

NCT Number: NCT02132624

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

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.

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Key information

Conditions

B Cell Lymphoma B Cell Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Uppsala University Hospital, Dept of Oncology

Uppsala, 75185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Relapsed or refractory CD19+ B-cell lymphoma or leukemia.
  • Measurable disease.
  • Performance status ECOG 0-2.
  • >18 years old.
  • Fertile females/males must consent to use contraceptives during participation of the trial.
  • Signed informed consent.

Exclusion criteria

  • Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
  • Patients with primary CNS lymphoma.
  • Known human immunodeficiency virus (HIV) infection.
  • Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
  • Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
  • Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
  • Patients that do not consent to that tissue and blood samples are stored in a biobank.
  • Pregnancy

Treatment and study plan

Autologous 3rd generation CD19-targeting CAR T cells

Biological

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

Primary outcomes

  1. CAR T cell persistence

    Time frame: At week 1 and 5, there after every 3 months post treatment up to 24 months

    Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood.

Secondary outcomes

  1. Tumor load

    Time frame: Every 3 months post treatment up to 24 months

    Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

Other outcomes

  1. B cell number and immunoglobulins

    Time frame: Weekly for 5 weeks, then every 3 months post treatment up to 24 months

    Number of blood B cells and immunoglobulins will be evaluated by routine diagnostics

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • AFA Insurance
  • Karolinska University Hospital
  • Swedish Cancer Society
  • Uppsala University Hospital

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 7, 2014
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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