Study Assessing the Effect of BK Specific CTL Lines Generated by ex Vivo Expansion in Patients With BK Virus Infection and JC Virus Infection
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|ClinicalTrials.gov Identifier: NCT02479698|
Recruitment Status : Recruiting
First Posted : June 24, 2015
Last Update Posted : May 21, 2018
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)|
|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|
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
- 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].
- 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.
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
|Contact: Amanda L. Olson, MD||713-792-8750|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Amanda L. Olson, MD||M.D. Anderson Cancer Center|