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Virus Therapy

CMV-Specific CTLs for CMV Infection

Phase 2

Recruiting

Led By Mitchell S 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

Donor Eligibility: Related donor available with a T-cell response to the CMV MACS® GMP PepTivator antigen(s) or third party related allogeneic donor (family donor > 1 HLA A, B, DR match to recipient) with IgG positive to CMV and/or a T-cell response to the CMV MACS® GMP PepTivator

Age: 0.1 to 79.99 years

Must not have

Known HIV infection

Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment

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 CMV CTLs can be safely administered to children, adolescents, and young adults with CMV infection who have not responded to previous treatment.

Who is the study for?

This trial is for children, adolescents, and young adults aged 0.1 to 30.99 years with refractory CMV infection after a stem cell or organ transplant, or those with primary immunodeficiencies. Participants must have tried antiviral therapy without success or cannot tolerate it due to side effects like low white blood cell counts or kidney issues.

What is being tested?

The study tests the use of virus-specific cytotoxic T-lymphocytes (CTLs) in patients who haven't responded well to standard treatments for CMV infections post-transplantation. These CTLs are developed using a special system and aim to fight off the persistent infection.

What are the potential side effects?

Potential side effects may include immune reactions as the body adjusts to new T-cells, infusion-related responses such as fever or chills, and possible worsening of existing conditions like GVHD if present.

Eligibility Criteria

Inclusion Criteria

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

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I have a family donor who matches me and is CMV positive or has a T-cell response to CMV.

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I am between the ages of 0 and 79.

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I can do most activities by myself.

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I am a woman who can have children and my pregnancy test is negative.

Exclusion Criteria

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

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I have been diagnosed with HIV.

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

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I have had CMV infection affecting my eyes or brain.

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I have been diagnosed with CMV retinitis.

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I am mostly bedridden and unable to care for myself.

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

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I have severe acute GVHD or widespread chronic GVHD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be followed 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

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 CMVExperimental Treatment1 Intervention

Patients with refractory CMV will be given one dose of CMV specific CTLs. HLA matched donors will get Dose 2.5 × 10(4) CD3/kg recipient weight; HLA mismatched will get 0.5x10(4) CD3/kg recipient weight. Additional doses may be given for a total of 5 doses if patients do not have a response to the first dose with a reduction in viral load to normal limits.

0 / 11Eligibility criteria met