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Virus Therapy

EBV-specific CTLs for EBV Infection

Phase 2

Recruiting

Led By Mitchell Cairo, MD

Research Sponsored by New York Medical College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with Epstein-Barr virus infections post allogeneic HSCT, primary immunodeficiencies or post solid organ transplant with increasing or persistent quantitative EBV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or progressive clinical symptoms attributable to EBV, including biopsy proven colitis, lymphadenopathy, hepatomegaly, splenomegaly, Medical intolerance to anti-viral therapies including intolerance to rituximab

Related donor available with a T-cell response to the EBV MACS® GMP PepTivator antigen(s) causing the therapy-refractory EBV infection

Must not have

Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of CTL infusion

Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patients will be followed for 12 weeks after each infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether related donor EBV-specific CTLs can be used to treat patients with EBV infection who have had an AlloHSCT, PID, or solid organ transplant.

Who is the study for?

This trial is for children and young adults aged 0.1 to 30 years with stubborn EBV infections after a stem cell or organ transplant, or those with primary immunodeficiencies. They must have tried antiviral treatments without success and not be on other experimental EBV studies, high-dose steroids, or have severe graft-versus-host disease.

What is being tested?

The study tests if special immune cells called cytotoxic T-lymphocytes from related donors can fight off tough Epstein-Barr Virus (EBV) infections in patients who haven't responded well to standard treatments after receiving transplants.

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to the immune system's response to infused cells such as fever, fatigue, pain at infusion site, allergic reactions, and possibly more serious complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have an Epstein-Barr virus infection after a transplant and my current treatment isn’t working.

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I have a donor whose T-cells react to the EBV infection I'm fighting.

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I am younger than 80 years old.

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I can do most of my daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking steroids equivalent to more than 0.5 mg/kg of prednisone at the time of my cell therapy infusion.

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I received a donor lymphocyte infusion less than 4 weeks ago.

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I am mostly bedridden and unable to care for myself.

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I have severe acute or extensive chronic GVHD.

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I am HIV positive.

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I am not pregnant, breastfeeding, and willing to use birth control during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patients will be followed for 12 weeks after each infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patients will be followed for 12 weeks after each infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be followed for 12 weeks after each infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Response to Treatment [Efficacy]

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Refractory EBVExperimental Treatment1 Intervention

Patients with refractory EBV will get one dose of EBV specific CTLs. If they don't show a response based on EBV PCRs, patients may get up to another 4 doses of EBV-CTLs (5 doses maximum)

0 / 10Eligibility criteria met