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Virus Therapy

CTL Therapy for Multivirus Infections

Phase 1
Waitlist Available
Led By Catherine Bollard, MD
Research Sponsored by Catherine Bollard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received prior myeoloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or PBSC within 12 months
Patient or parent/guardian capable of providing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will test whether or not these CTLs can prevent or treat CMV, EBV and adenovirus infections after transplant.

Who is the study for?
This trial is for patients with blood cancers or genetic diseases who've had a stem cell transplant within the last year. They should be at risk of, or currently fighting, CMV, EBV, or Adenovirus infections. Participants need to have stable vital signs and organ function and not be on high doses of steroids. Pregnant women and those with uncontrolled cancer relapse or other severe infections cannot join.Check my eligibility
What is being tested?
The study tests whether T cells (CTLs) grown from donors can prevent or treat viral infections like CMV, EBV, and Adenovirus in patients post-transplant. CTLs are trained in the lab to fight these viruses and then infused into patients to boost their immune response against potential life-threatening infections.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar treatments often involve risks such as infusion reactions (like fever or chills), increased vulnerability to other infections due to immune system modification, allergic responses, and potential GVHD (graft-versus-host disease).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a stem cell transplant from a donor within the last year.
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I (or my guardian) can understand and agree to the study's terms.
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I can do most activities but may need help.
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I am taking less than 0.5 mg/kg/day of prednisone.
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I am receiving cell therapy for EBV, CMV, or Adenovirus infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Assessments of patients with adverse events after mukti-virus specific CTL infusion.
Secondary outcome measures
Assessments of viral load response to the CTL infusion

Trial Design

2Treatment groups
Experimental Treatment
Group I: CTL for CMV seropositive donorsExperimental Treatment1 Intervention
CTL for CMV seropositive donors - Allogeneic Multivirus - Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton) for CMV seropositive donors- three different dose levels are selected, starting with 5 x 106 (a T cell number more than an order of magnitude lower than that administered at the time of an unmanipulated marrow infusion), followed by 1 x 107 and a final dose 2 x 107 mCTLs/m2. Two additional doses (at the same level)will be administered 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL.
Group II: CTL for CMV naïve donorsExperimental Treatment1 Intervention
CTL for CMV naïve donors - Allogeneic Multivirus - Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton)for CMV naïve donors-each group will undergo an identical dose escalation. Three different dose levels are selected, starting with 5 x 106 (a T cell number more than an order of magnitude lower than that administered at the time of an unmanipulated marrow infusion), followed by 1 x 107 and a final dose 2 x 107 mCTLs/m2. Two additional doses (at the same level)will be administered 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL.

Find a Location

Who is running the clinical trial?

Catherine BollardLead Sponsor
13 Previous Clinical Trials
304 Total Patients Enrolled
Catherine Bollard, MDPrincipal InvestigatorChildren's National Research Institute
6 Previous Clinical Trials
76 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Allogeneic Multivirus - Directed Cytotoxic T Lymphocytes (CTL)
Catherine Bollard 2014. "Allogeneic Multivirus - Directed Cytotoxic T Lymphocytes (CTL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01945814.
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~2 spots leftby Apr 2025
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