Study of LMP1- and LMP2- Specific Cytotoxic T-Lymphocytes (CTL)

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Brief Title

Study of LMP1- and LMP2- Specific Cytotoxic T-Lymphocytes (CTL)

Official Title

Administration of LMP1- and LMP2-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody Administration to Patients With EBV-Positive Nasopharyngeal Carcinoma

Brief Summary

      In this study NPC patient will receive 4 days of treatment with CD45 antibody followed by one
      dose of LMP1- and LMP2-CTL. From this, we can learn if treating the patient first with the
      CD45 antibody will also let LMP1- and LMP2-CTL we give grow better. In addition, we will find
      out, if LMP1- and LMP2-CTL are safe and have enhanced anti-tumor activity in comparison to
      standard EBV-CTL.

      This study aims to determine the safety of autologous LMP1- and LMP2- specific cytotoxic
      T-lymphocytes (CTL) in combination with CD45 monoclonal antibody (MAb) in patients with
      EBV-positive nasopharyngeal carcinoma (NPC).

      And to obtain information on the expansion, persistence and anti-tumor effects of autologous
      LMP1- and LMP-2 specific CTL given after lymphodepletion with CD45 MAb in patients with
      EBV-positive NPC.
    

Detailed Description

      While patients with nasopharyngeal carcinoma (NPC) may be cured by chemotherapy and
      radiotherapy, the outlook for patients who are resistant to this treatment or who relapse is
      poor. Almost all patients with undifferentiated nasopharyngeal carcinoma have the EBV virus
      in their tumors which may be a target for immunotherapy approaches. We have successfully used
      specialized immune system cells grown in the laboratory and trained to recognize and kill EBV
      infected cells (EBV-specific cytotoxic T-lymphocytes [EBV-CTL]) to prevent and treat another
      type of cancer called post transplant lymphoma that occurs after bone marrow transplant. In
      post transplant lymphoma, the tumor cells have 9 proteins made by EBV on their surface.
      However in nasopharyngeal carcinoma that develops in patients with a normal immune system,
      the tumor cells only express 2 EBV proteins that are much harder for the immune system to
      recognize. In a previous study we made EBV-CTL that recognized all 9 proteins and gave them
      to patients with NPC. For patients without evidence of active disease at the time of therapy,
      there disease remains in remission. For those patients with active disease at the time they
      received CTL, some patients had a partial response to this therapy, and only three patients
      had a complete response. We think the main reason for this is that many of the T cells
      reacted with EBV proteins that were not on the tumor cells, and the other is that the infused
      T cells have not enough space to grow.

      The two EBV proteins present on NPC tumor cells that are good targets for T-cell therapies
      are called LMP1 and LMP2. We are therefore planing to generate T cells specific for LMP1 and
      LMP2 and infuse these cells into NPC patients. To make LMP1- and LMP2-CTL, we have obtained
      blood from the patients and grown special type of cell called a dendritic cell (DC) and EBV
      infected lymphoblastoid cells (LCL). We have then transferred an adenovirus vector that
      carries the LMP1 and LMP2 gene into the DC and the LCL. These DC and LCL are then treated
      with radiation so they cannot grow and are used to stimulate and expand LMP1- and LMP2-CTL.
      This stimulation trains the T cells to kill cancer cells with LMP1 and LMP2 on their surface.

      To 'create space' for EBV-CTL growth after infusion in NPC patients we have already used a
      special protein called a CD45 antibody, which removes for a short period of time most of the
      patient's T cells. The preliminary results of this study is encouraging: the use of the CD45
      antibody is safe and we observed enhanced EBV-CTL growth after infusion. In addition, all
      patients who has EBV-CTL growth had clinical responses.

      We and others have demonstrated the feasibility of CTL therapy for EBV-positive NPC in
      immunocompetent patients, providing preliminary evidence of anti-tumor activity of EBV-CTL in
      this patient population. Not all patients responded, however, suggesting the need for further
      improvement. We propose that CTL failure can be overcome by increasing the specificity of the
      infused CTL product. That is, infusion of CTL specific for LMP1 and LMP2 will produce greater
      clinical benefit than EBV-specific CTL. The rationale for this approach is straight forward:
      EBV-specific CTL lines generated by standard methods are dominated by T-cell clones not
      reactive to the subdominant EBV proteins LMP1 and LMP2 expressed in NPC. We also propose that
      the failure of adoptively transferred CTL to measurably expand in the peripheral blood of NPC
      patients is a consequence both of lymphoid homeostasis in these lympho-replete patients and
      of the inhibitory T-cell infiltrate at the sites of disease. We will therefore use monoclonal
      antibodies targeting the CD45 antigen (CD45 MAbs), to lymphodeplete NPC patients prior to the
      infusion of EBV-specific CTL. Preliminary results indicate that CD45 MAb depletion can
      augment CTL expansion, and that such expansion is associated with a higher disease response
      rate. We will confirm and extend these promising new data in this Phase I clinical trial.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

To determine the safety of autologous LMP1- and LMP2- specific cytotoxic T-lymphocytes (CTL) in combination with CD45 monoclonal antibody (MAb) in patients with EBV-positive nasopharyngeal carcinoma (NPC).

Secondary Outcome

 To obtain information on the expansion, persistence and anti-tumor effects of autologous LMP1- and LMP-2 specific CTL given after lymphodepletion with CD45 MAb in patients with EBV-positive NPC.

Condition

NASOPHARYNGEAL CARCINOMA

Intervention

genetically modified CTLs in combo with CD45 antibodies

Study Arms / Comparison Groups

 Patients
Description:  Patients with Nasopharyngeal Carcinoma in first or subsequent relapse or with primary refractory disease or high risk (T3 or T4, or node positive disease) in whom the EBV-genome or antigens have been demonstrated in tissue biopsies

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Genetic

Estimated Enrollment

0

Start Date

August 2007

Completion Date

August 2010

Primary Completion Date

August 2010

Eligibility Criteria

        Inclusion Criteria:

        All patients with NPC in first or subsequent relapse or with primary refractory disease or
        high risk (T3 or T4, or node positive) in whom the EBV genome or antigens have been
        demonstrated in tissue biopsies will be eligible for this trial.

        Any patient with EBV positive NPC, in relapse or with primary resistant disease

        Patients with a life expectancy 6 weeks or greater.

        Patients with a Karnofsky score (age at least 16; for Karnofsky scale see full protocol) or
        Lansky score (less than 16; for Lansky scale see full protocol) of 50 or greater as
        described below:

        Patients with bilirubin <2x normal, SGOT <3x normal, and Hgb greater than 8.0.

        Patients with a creatinine 2x normal or less for age.

        Patients should have been off other investigational therapy for one month prior to entry in
        this study.

        Patient, parent/guardian able to give informed consent.

        Exclusion Criteria:

        Severe intercurrent infection.

        Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this
        research. The male partner should use a condom.

        Note: Patients who would be excluded from the protocol strictly for laboratory
        abnormalities can be included at the investigator¡-s discretion after approval by the CCGT
        Protocol Review Committee and the FDA reviewer.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Stephen Gottschalk, MD, , 



Administrative Informations


NCT ID

NCT00515957

Organization ID

20996

Secondary IDs

20996-DELLA

Responsible Party

Principal Investigator

Study Sponsor

Baylor College of Medicine

Collaborators

 The Methodist Hospital System

Study Sponsor

Stephen Gottschalk, MD, Principal Investigator, Baylor College of Medicine


Verification Date

April 2012