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CAR T-cell Therapy

Adoptive Immunotherapy for Viral Infections

Phase 1 & 2
Recruiting
Research Sponsored by Catherine Bollard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lansky/Karnofsky scores ≥60
Recipients of at least one unmanipulated cord blood unit transplant at risk for or with specific infections
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is a Phase I-II dose-finding trial to determine the optimal dose of intravenous injection of donor-derived cytotoxic T lymphocytes specific for CMV, EBV, BKV, and Adenovirus.

Who is the study for?
This trial is for pediatric and adult patients with malignant or nonmalignant diseases who are candidates for a cord blood transplant. They must have a certain level of physical function, no severe organ damage, and be at least 30 days post-transplant without significant graft-versus-host disease. It's not for pregnant women, those with very low performance status, uncontrolled infections other than the viruses in question, or those who've received another investigational product within 28 days.Check my eligibility
What is being tested?
The trial tests different doses of donor-derived T cells that fight CMV, EBV, BKV and Adenovirus in patients receiving cord blood transplants. Up to 36 patients will receive one of three escalating dose levels determined by an adaptive method to find the optimal balance between effectiveness and toxicity.See study design
What are the potential side effects?
Potential side effects may include immune reactions where the body attacks its own tissues (GVHD), infusion-related reactions like fever or chills during T cell administration, increased risk of infection due to immune system suppression from treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may need occasional help.
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I received a cord blood transplant and am at risk for certain infections.
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My liver is functioning well.
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I do not have severe graft-versus-host disease.
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My cord blood unit matches me on 4-6 key immune system markers.
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My kidneys are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with investigational product-related adverse events as assessed by CTCAE v4.03
Secondary outcome measures
Impact of CMV/AdV /EBV/BKV specific T cells will be measured by existence of cells in the system.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CMV/AdV /EBV/BKV specific T cellsExperimental Treatment1 Intervention
CMV/AdV /EBV/BKV specific T cells will be thawed and transferred to a syringe given by slow intravenous injection over 1-2 minutes. Three dose levels will be explored. The lowest dose level will be 1x107cells/m2 and the highest will be 5x107/m2.

Find a Location

Who is running the clinical trial?

Catherine BollardLead Sponsor
13 Previous Clinical Trials
295 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
2,973 Previous Clinical Trials
1,789,285 Total Patients Enrolled

Media Library

CMV/AdV /EBV/BKV specific T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03594981 — Phase 1 & 2
Viral Infections Research Study Groups: CMV/AdV /EBV/BKV specific T cells
Viral Infections Clinical Trial 2023: CMV/AdV /EBV/BKV specific T cells Highlights & Side Effects. Trial Name: NCT03594981 — Phase 1 & 2
CMV/AdV /EBV/BKV specific T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03594981 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to sign up for this test now?

"This study is actively recruiting patients, as reported on clinicaltrials.gov. The original posting date for the trial was 1/24/2018, and it was most recently edited on 8/6/2021."

Answered by AI

How many people have the opportunity to enroll in this clinical trial?

"That is correct. The information available on clinicaltrials.gov verifies that this study is presently looking for participants. This trial was initially posted on January 24th, 2018 and was last updated on August 6th, 2021. Presently, the clinical trial needs to recruit 36 patients from 2 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
How old are they?
18 - 65
What site did they apply to?
M.D. Anderson Cancer Center (MDACC)
Children's National Health System
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. M.D. Anderson Cancer Center (MDACC): < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis
Catherine Bollard 2018. "Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03594981.
All > Ebv
~1 spots leftby Jul 2024
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