ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Assessing the Effect of BK Specific CTL Lines Generated by ex Vivo Expansion in Patients With BK Virus Infection and JC Virus Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02479698
Recruitment Status : Recruiting
First Posted : June 24, 2015
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs) can help to control BK viral infection and JC viral infection. Researchers also want to learn about the safety of giving CTLs to patients with BK and/or JC infection.

CTLs are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections.

This is an investigational study. The use of CTLs to treat BK infection and JC infection is not FDA-approved or commercially available. CTLs are currently being used for research purposes only.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.


Condition or disease Intervention/treatment Phase
BK Virus Biological: Cytotoxic T lymphocytes (CTLs) Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Assessing the Effect of BK Specific CTL Lines Generated by ex Vivo Expansion in Patients With BK Virus Infection and JC Virus Infection
Actual Study Start Date : July 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cytotoxic T lymphocytes (CTLs)

CTL product given as single infusion within 5 days of enrollment. CTL dose infused not greater than 2 x 10^5.

If a participant has a partial response, stable disease or progressive disease they will be eligible to receive seven (7) additional doses of CTL at a minimum of 2 weeks interval from the previous CTL infusion

Biological: Cytotoxic T lymphocytes (CTLs)

CTL dose infused will not be greater than 2 x 10^5 cells/kg BKV-specific CD3+ T cell line as a single infusion.

If a participant has a partial response, stable disease or progressive disease they will be eligible to receive seven (7) additional doses of CTL at a minimum of 2 weeks interval from the previous CTL infusion If participant has a partial response, stable disease or progressive disease, they will be eligible to receive one additional dose of CTL at a minimum of 2 weeks interval from the first CTL infusion.

Other Name: CTL




Primary Outcome Measures :
  1. Response of BK-specific T-cells (CTLs) for Allogeneic HSCT Participants who have BK Viruria/Viremia (BKV) and Macroscopic Hematuria [ Time Frame: 28 days ]
    Best response defined as R1 = [BKV grade = 0 or 1 at each of days 14, 21, and 28]. Second best response is defined as R2 = [BKV grade 2 or higher at day 14, 21, or 28, followed by a second dose, followed by (i) BKV grade 0 or 1 or (ii) a drop of at least 1 grade level from baseline]. Response is R = [R1 or R2].

  2. Acute Graft Versus Host Disease (GVHD) [ Time Frame: 45 days ]
    The adverse event to be monitored is G34 = [grade 3 or 4 GVHD within 45 days from the start of CTL therapy]. Any patient who discontinues therapy or drops out prior to day 45 will be scored, conservatively, as having G34.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with any type of malignancies; and/or HIV/AIDs; and/or history of solid organ transplant; and/or Merkel polyoma-virus related Merkel cell tumor(s) with measurable disease on imaging per RECIST criteria.
  2. Patients with microscopic hematuria OR biopsy proven BK nephritis and urine or blood PCR positive for BK virus and/or JC viral encephalitis.
  3. Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day of prednisone.
  4. Patients who are currently receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion.
  5. Written informed consent and/or signed assent from patient, parent or guardian.
  6. Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.

Exclusion Criteria:

  1. Patients receiving prednisone > 0.5 mg/kg/day at time of enrollment, or have received ATG within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.
  2. Patients with other uncontrolled infections (except HIV/AIDS). For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
  3. Patients with active acute GVHD grades II-IV.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479698


Contacts
Contact: Amanda L. Olson, MD 713-792-8750

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Amanda L. Olson, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02479698     History of Changes
Other Study ID Numbers: 2014-0279
NCI-2015-01264 ( Registry Identifier: NCI CTRP )
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Stem cell transplant
Human Leukocyte Antigen
HLA
BK specific CTL lines
BK-CTLs
Hematopoietic stem cell transplantation
HSCT
BK Infection
Cytotoxic T lymphocytes
CTLs
Myeloablative
Non-myeloablative
Graft Versus Host Disease
GVHD

Additional relevant MeSH terms:
Infection
Virus Diseases